invitation to subscribe for shares in camurus ab · 2019. 5. 24. · the rights issue in brief...

Invitation to subscribe for shares in Camurus AB

Please note that the subscription rights are expected to have an economic value.In order to not lose the value of the subscription rights, holders must either:• Exercise the subscription rights received and subscribe for new shares no later than 25 March 2019, or• Sell the subscription rights received, but not exercised, no later than 21 March 2019.Please note that shareholders with nominee-registered shareholdings subscribe for new shares through their custodian/nominee.

The distribution of this prospectus and the subscription for new shares are subject to restrictions in certain jurisdictions (see “Selling and transfer restrictions”).

FINANCIAL ADVISORS

IMPORTANT INFORMATIONFor certain definitions used in this prospectus, see “Certain definitions” on the next page.

A Swedish version of this prospectus has been approved and registered by the Swedish Financial Supervisory Authority (the “SFSA”) in accordance with Chapter 2, sections 25 and 26 of the Swedish Financial Instruments Trading Act (lagen (1991:980) om handel med finansiella instrument). Approval and registration does not imply that the SFSA guarantees that the information in the prospectus is accurate or complete.

The prospectus and the offering hereunder are governed by Swedish law. Disputes arising in connection with this prospectus, the offering and related legal matters shall be settled exclusively by Swedish courts. The prospectus has been prepared in both Swedish and English language versions. In the event of any conflict between the versions, the Swedish version shall prevail.

Camurus has not taken, and will not take any actions to allow a public offering in any jurisdiction other than Sweden. The offering is not being made to persons resident in the United States, Canada, Japan, Australia, New Zealand, South Africa, Hong Kong, Singapore or any other jurisdiction where par-ticipation would require additional prospectuses, registration or measures besides those required by Swedish law. Consequently, the prospectus may not be distributed in or into the mentioned countries or any other country or jurisdiction in which distribution or the offering in accordance with this prospectus require such measures or otherwise would be in conflict with applicable regulations. Subscription of shares and other acquisitions of securities in violation of the restrictions described above may be void. Recipients of this prospectus are required to inform themselves about, and comply with, such restrictions. Any failure to comply with the restrictions described may result in a violation of applicable securities regulations. For further information, see “Selling and transfer restrictions”.

Investing in shares is associated with risk (see “Risk factors”). When an investor makes an investment decision, he or she must rely on his or her own analysis of Camurus and the offering in accordance with this prospectus, including applicable facts and risks. Potential investors should, before making an investment decision, engage their own professional advisers and carefully evaluate and consider their investment decision. Investors may only rely on the information in this prospectus and any possible supplements to this prospectus. No person is authorized to provide any information or make any state-ments other than those made in this prospectus. Should such information or statement nevertheless be provided or be made it should not be considered to have been approved by Camurus, and Camurus is not responsible for such information or statements. Neither the publication of this prospectus nor any transaction made in respect of it shall be deemed to imply that the information in this prospectus is accurate or applicable at any time other than on the date of the publication of this prospectus or that there have been no changes in Camurus’ business since this date. If significant changes relating to the information contained in this prospectus occur, such changes will be announced in accordance with the provisions on prospectus supplements under the Swedish Financial Instruments Trading Act.

As a condition for subscription of shares under the offering in this prospectus, each person applying for subscription of shares shall be deemed to have made or, in some cases, be required to make, certain representations and warranties that will be relied upon by Camurus and its advisors (see “Selling and transfer restrictions”). Camurus reserves the right to declare null and void any subscription of shares that Camurus and its advisors believe may give rise to a breach or violation of any law, rule or regulation in any jurisdiction.

Important information to investors in the United States No subscription rights, paid subscription shares (betalda tecknade aktier, “BTA”) or new shares in Camurus (“Securities”) have not been, and will not, be, registered under the United States Securities Act of 1933, as amended (the “Securities Act”) or the securities legislation of any state or other jurisdiction of the United States and may not be offered, subscribed for, exercised, pledged, sold, resold, granted, delivered or otherwise transferred, directly or indirectly, within the United States except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with any applicable securities legislation in any state or other jurisdiction of the United States. The Securities are being offered outside the United States in offshore transactions in reliance on Regulation S under the Securities Act. A public offering will not be made in the United States. Any offering of the Securities made in the United States will be made pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act, to a limited number of existing shareholders that (i) are qualified institutional buyers as defined in Rule 144A under the Securities Act (“QIBS”), and (ii) have executed and delivered an investor letter, in form and substance acceptable, to Camurus. Persons receiving the prospectus are hereby notified that Camurus may be relying on an exemption from the registration requirements of Section 5 of the Securities Act. For a description of these and certain further restrictions regarding the Securities and the distribution of this prospectus, see “Selling and transfer restrictions”.

Up until 40 days after the initiating of the rights issue, an offer or a transfer of Securities within the United States made by a securities broker (regardless of whether such securities broker participates in the rights issue or not) may imply a breach of the registration requirements of the Securities Act.

The Securities have not been approved or disapproved by the U.S. Securities and Exchange Commission (“SEC”), any state regulatory authority in the United States or any other U.S. regulatory authority nor have any of the foregoing authorities passed upon or endorsed the merits of the offering or the accuracy or adequacy of this document. Any representation to the contrary is a criminal offense in the United States.

Important information to investors in the EEANo public offering of Securities is made to any countries within the European Economic Area (“EEA”) other than Sweden. In other member states of the EEA which have implemented European Parliament and Council Directive 2003/71/EC (the “Prospectus Directive”), such offering may be made only under an exemption in the Prospectus Directive as well as every relevant implementation measure (including measures to implement European Parliament and Council Directive 2010/73/EU). For additional information, see “Selling and Transfer Restrictions”.

Forward-looking statementsThe prospectus contains certain forward-looking statements that reflect Camurus’ present view of future events as well as financial and operational devel-opment. Words such as “intend”, “assess”, “expect”, “may”, “plan”, “believe”, “estimate” and other expressions entailing indications or predictions of future development or trends, not based on historical facts, constitute forward-looking statements. Forward-looking statements are inherently associated with both known and unknown risks and uncertainties as it depends on future events and circumstances. A forward-looking statement is not a guarantee of future results or development, and actual outcomes may differ materially from those set out in the forward-looking statements.

Factors that may cause Camurus’ future results and development to differ from the forward-looking statements include, but are not limited to, those described in “Risk factors”. The forward looking statements contained in this prospectus apply only as at the date of this prospectus. Camurus does not undertake any obligation to publicly announce any update or change in forward-looking statements as a result of new information, future events or similar circumstances other than as required by applicable laws and regulations.

Presentation of financial informationCertain figures in this prospectus, including financial data, have been rounded. Accordingly, figures shown in totals in certain tables may not be an exact arithmetic aggregation of the figures which precede them.

I N V I TAT I O N T O S U B S C R I B E F O R S H A R E S I N C A M U R U S A B 1

Table of contentsSummary 2

Risk factors 10

Invitation to subscribe for shares in Camurus 17

Background and reasons 18

Business description and market overview 20

Selected consolidated historical financial

information 52

Operating and financial review 59

Capitalization, indebtedness and other

financial information 61

Board of Directors, Group Management

and Auditor 63

Share capital and ownership structure 68

Articles of association 71

Legal considerations and supplementary

information 72

Certain tax issues in Sweden 75

Selling and transfer restrictions 77

Glossary 81

Addresses 83

Certain definitionsIn this prospectus, the following definitions are used:“Camurus” or the “Company” refers to, depending on the context, Camurus AB (publ) (corporate ID No. 556667-9105) or the group in which Camurus AB (publ) is the parent company.The “Group” refers to Camurus AB (publ) and its subsidiaries.“Joint Global Coordinators” refers to Carnegie Investment Bank AB (publ) (“Carnegie”) and Jefferies International Limited (“Jefferies”).“Euroclear Sweden” refers to Euroclear Sweden AB.“Nasdaq Stockholm” refers to the Swedish regulated market Nasdaq Stockholm or its operator Nasdaq Stockholm AB, as the context may require.“SEK”, “EUR”, “GBP” and “USD” refers to Swedish kronor, Euro, British pound and U.S. dollars, respectively. M indicate millions.

For additional definitions and a glossary, please refer to “Glossary”.

The rights issue in briefPreferential rightsEach existing share in Camurus entitles to one (1) subscription right. Four (4) subscription rights entitles to subscription for one (1) new share. Shares not subscribed for with preferential rights shall be offered to shareholders and other investors.

Subscription priceSEK 42 per share.

Record date for participation in the rights issue7 March 2019

Subscription period11 March–25 March 2019

Trading in subscription rights11 March–21 March 2019

Trading in BTA11 March–27 March 2019

Subscription with preferential rightsSubscription by exercise of subscription rights is made during the subscription period through simultaneous cash payment.

Subscription without preferential rightsApplication for subscription without preferential rights shall be made to Carnegie no later than 25 March 2019 on a separate application form that can be obtained from Carnegie and is available on www.|carnegie.|se or www.|camurus.|com. Payment for allotted shares shall be made in accordance with instruc-tions on the notice of allotment. Custody account holders shall instead apply with, and in accordance with instructions from, the custodian.

Other informationTicker: CAMXISIN Code share: SE0007692850ISIN Code subscription right: SE00123571732ISIN Code BTA: SE0012351740

Financial informationAnnual report 2018: 5 April 2019Interim report January-March 2019: 9 May 2019Interim report January-June 2019: 18 July 2019

2 I N V I TAT I O N T O S U B S C R I B E F O R S H A R E S I N C A M U R U S A B

Summary

Prospectus summaries consist of information requirements presented in “items ”. The items are numbered in sections A–E (A.1–E.7).

The summary in this prospectus includes all of the items required in a summary for the relevant type of security and issuer. However, since certain items are not applicable to all types of prospectuses, there may be gaps in the numbering of the items.

Even if an item is required to be included in the summary for the relevant type of security and issuer, it is possible that no relevant information can be provided regarding the item. In such case, the information is replaced by a brief description of the item together with the indication “not applicable”.

SECTION A – INTRODUCTIONS AND WARNINGS

A.1 Introduction and warnings

This summary should be read as an introduction to the prospectus. Any decision to invest in the securities should be based on consideration of the prospectus as a whole

by the investor. Where a claim relating to the information in this prospectus is brought before a court, the plaintiff investor

might, under the national legislation of the Member States, have to bear the costs of translating the prospec-tus before the legal proceedings are initiated.

Civil liability may attach to those persons who produced the summary, including any translation thereof, only if the summary is misleading, inaccurate or inconsistent with other parts of the prospectus or if, together with other parts of the prospectus, it fails to provide key information to help investors when considering investing in such securities.

A.2 Consent to use the prospectus

Not applicable. Financial intermediaries are not entitled to use the prospectus for subsequent resale or final placement of securities.

SECTION B – ISSUER

B.1 Legal and commer-cial name

The legal (and commercial) name of the Company is Camurus AB.

B.2 Domicile and legal form

The registered office of the Board of Directors is situated in Lund, Sweden. The Company was incorporated in Sweden and is a Swedish public limited liability company governed by the Swedish Companies Act (aktie-bolagslagen (2005:551)).

B.3 Nature of opera-tions and principal activities

Camurus is a Swedish research-based pharmaceutical company committed to developing and commer-cialising innovative and long-acting medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the proprietary FluidCrystal® drug delivery technologies and an extensive research and development (“R&D”) expertise. The clinical pipeline includes innovative products for treatment of opioid dependence, pain, cancer, neuroendocrine tumors, acromegaly and genetic obesity, developed in-house and in collaboration with international pharmaceutical companies. Camurus’ activities covers R&D, manufacturing, distribution, marketing and sales.

B.4a Recent trends In addition to that the entire global pharmaceutical market, and in particular the specialty medicines market, is growing and is expected to keep growing steadily the next years it is Camurus’ assessment that the market trend primarily impacting on Camurus and its activities is the fast growing opioid crisis. In the US, opioid addiction has reached epidemic proportions, threatening not only public health but economic output and national security. An estimated 11.8 million individuals misuse opioids in the US, of which 2.1 million reach the criteria for diagnosis of opioid use disorder.1) In Europe, an estimated 1.3 million people engage in high-risk opioid use, with only about 630,000 receiving medical treatment.2)

1) SAMHSA, Results from the 2016 National Survey on Drug Use and Health, Sep. 2017.2) European Drug Report 2018, EMCDDA, http|://www.|emcdda.|europa.|eu/edr2018_en.

B.5 Group Camurus is the ultimate parent company of the Group, which comprises nine legal entities in eight countries.


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B.6 Major shareholders, etc.

In Sweden, the lowest threshold for mandatory reporting of changes in shareholdings (so-called flagging) is 5 percent of all shares or voting rights in respect of all shares. The table below shows shareholders with holdings corresponding to at least 5 percent of the shares and voting rights in the Company as of 31 Janu-ary 2019.

Holder/nominee/custodian Total No. of sharesShare capital and

Voting rights, %

Sandberg Development 20,414,978 53.19Gladiator 2,495,000 6.5Other shareholders 15,471,508 40.31Total 38,381,486 100.0Source: Euroclear Sweden.

Sandberg Development AB (“Sandberg Development”) can exercise significant influence over the Com-pany in matters where the shareholders have a voting right. Due to its shareholding, Sandberg Development may put through several proposals at a general meeting, even if other shareholders do not agree with the proposal. Sandberg Development is therefore able to exercise significant influence over Camurus. The control is, however, limited in accordance with the rules set out in the Swedish Companies Act (2005:551) on minority protection.

B.7 Selected histor-ical key financial information

The below condensed financial statements (as well as measures defined under International Financial Reporting Standards (“IFRS”)) pertaining to the full years 2016 and 2017 have been derived from Camurus’ annual reports for the financial years 2016–2017, which have been prepared in accordance with IFRS as they have been adopted by the EU and audited by the Company’s auditor. The condensed financial statements (as well as measures defined under IFRS) pertaining to 2018 have been derived from Camurus’ interim report for the period January–December 2018, which has been prepared in accordance with IAS 34 Interim Financial Reporting and the Swedish Annual Accounts Act (årsredovisningslagen (1995:1554)). The interim report has, as regards January–September 2018, been reviewed by the Company’s auditor.

The summary also includes certain measures that are not defined under IFRS (alternative performance measures). These non-IFRS measures have not been reviewed or audited by the Company’s auditor. Camurus believes these measures are commonly used by certain investors, securities analysts and other interested parties as supplementary measures of performance trends and financial position. Camurus’ non-IFRS measures may not be comparable to other similarly titled measures presented by other companies and have certain limitations as analysis tools. Consequently, they should not be considered separately, or as an alternative to Camurus’ financial information prepared in accordance with IFRS.

Condensed consolidated income statementSEK thousand 2018 2017 2016Net sales 49,321 54,308 113,737Cost of sold goods –6,822 –1,356 –2,140Gross profit 42,499 52,952 111,597

Marketing and distribution costs –100,884 –45,893 –24,738Administrative expenses –21,999 –26,590 –17,985Research and development costs –207,664 –222,939 –172,077Other operating income 830 93 751Other operating expenses – –1,147 –Operating result –287,218 –243,524 –102,452

Finance income 175 174 95Finance expenses –25 –18 –1,002Net financial items 150 156 –907

Result before tax –287,068 –243,368 –103,359Income tax 52,392 52,794 22,367Result for the year –234,676 –190,574 –80,993


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B.7 Selected historical key financial infor-mation (cont’d)

Condensed consolidated balance sheetSEK thousand 31 Dec 2018 31 Dec 2017 31 Dec 2016ASSETSFixed assetsIntangible assets 15,975 16,653 18,741Tangible assets 10,899 9,902 9,759Financial assets 170,955 114,997 61,685Total fixed assets 197,829 141,552 90,185

Current assetsInventories 9,830 3,553 12,380

Current receivablesTrade receivables 2,280 5,781 8,304Other receivables 9,604 3,285 3,855Prepayments and accrued income 10,804 7,239 16,459

Cash and cash equivalents 134,377 314,524 508,594Total current assets 166,895 334,382 549,592TOTAL ASSETS 364,724 475,934 639,776

EQUITY AND LIABILITIESEquityShare capital 960 932 932Other contributed capital 744,140 642,175 631,034Retained earnings, including comprehensive result for the period –492,776 –258,107 –67,549Total equity 252,324 385,000 564,418LiabilitiesShort-term liabilitiesTrade payables 35,781 15,086 17,560Income taxes 1,708 517 –Other liabilities 3,549 2,672 2,571Accrued expenses and deferred income 71,362 72,659 55,228Total short-term liabilities 112,400 90,934 75,358TOTAL EQUITY AND LIABILITIES 364,724 475,934 639,776

Condensed consolidated cash flow analysisSEK thousand 2018 2017 2016Cash flow from operating activities –274,084 –203,084* –207,788Cash flow from investing activities –4,761 –2,143 –4,567Cash flow from financing activities 99,851 11,141 4,853Net cash flow for the year –178,994 –194,086 –207,502Cash and cash equivalents at beginning of the year 314,524 508,594 716,096Cash and cash equivalents at the end of the year 134,377 314,524* 508,594

* As from the full year report for 2018, exchange-rate differences from conversion of subsidiaries outside of Sweden are reported under the item “Comprehensive income for the period”. Adjustments has been made accordingly for 2017, which has entailed that the exchange-rate differences for 2017 amounting to SEK 16 thousand has been moved, within consolidated equity from the item “Retained earnings” to the item “Comprehensive income for the period”. The items “Adjustment for non-cash items” and “Translation difference in cash flow and liquid assets” in the consolidated cash flow statement have been adjusted accordingly with SEK 16 thousand.


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Selected key operating metrics and data per shareMSEK 2018 2017 2016Income statementNet sales1) 49.3 54.3 113.7Operating result2) –287.2 –243.5 –102.5Result for the period1) –234.7 –190.6 –81.0R&D costs as percentage of operating expenses (%)2) 63% 75% 80%

Balance sheetEquity2) 252.3 385.0 564.4Cash and cash equivalents2) 134.4 314.5 508.6Equity/assets ratio (%)2) 69% 81% 88%Total assets1) 364.7 475.9 639.8

Cash flowCash flow from operating activities2) –274.1 –203.1 –207.8

Data per shareAverage number of shares, before dilution1) 37,842,034 37,281,486 37,281,486Average number of shares, after dilution1) 39,231,356 38,058,289 37,487,937Earnings per share, before dilution (SEK)1) –6.20 –5.11 –2.17Earnings per share, after dilution (SEK)1) –6.20 –5.11 –2.17Equity per share, before dilution (SEK)2) 6.67 10.33 15.14Equity per share, after dilution (SEK)2) 6.43 10.12 15.06

OtherNumber of employees at end of period2) 94 71 62Number of employees in R&D at end of period2) 58 48 44

Measures for the interim period January–December 2018 are not audited.1) IFRS measure, audited.2) Non-IFRS measure, not audited.

Definitions of IFRS measuresMeasure DefinitionNet sales Total sales proceeds relating to goods and services less

discounts, value added tax and other taxes attributable to the sales.

Result for the period Net earnings, the Company’s profit or loss after taxes.Total assets The Group’s total assets and liabilities respectively, as well

as equity. Average number of shares, before dilution Average number of shares, before adjustment for dilution

due to new shares.Average number of shares, after dilution Average number of shares, adjusted for dilution due to new

shares.Earnings per share, before dilution (SEK) Earnings divided by the average number of shares, before

dilution.Earnings per share, after dilution (SEK) Earnings divided by the average number of shares, adjusted

for dilution.


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Definitions of non-IFRS measuresMeasure DefinitionOperating result (EBIT) Profit/loss for the period before financial revenues, financial

costs and income tax on the result for the year.R&D costs as a percentage of operating expenses (%)

Research and development costs divided by operating expenses (marketing and distribution costs, administrative expenses and research and development costs).

Equity Equity is the difference between the Group’s assets and liabilities. Refers to the Group’s own resources.

Cash and cash equivalents Cash and cash bank balances.Equity/assets ratio (%) Equity divided by total capital.Cash flow from operating activities Cash flow from operating activities after changes in working

capitalEquity per share before dilution (SEK) Equity divided by number of shares at end of period, before

dilution.Equity per share after dilution (SEK) Equity divided by number of shares at end of period,

adjusted for dilution.Number of employees at end of period Number of employees at end of period (Compared with aver-

age number of employees according to IFRS)Number of employees in R&D at end of period

Number of employees mainly working within research and development at end of period

Significant changes since 31 December 2018On 11 January 2019, Camurus announced that the European launch of the Company’s long-acting depot treatment of opioid dependence, Buvidal®, had been initiated and that the medicine is available for health-care providers and patients in Finland and Sweden. On 6 February 2019, the Company announced its intention to carry out a rights issue on approximately SEK 403 million with preferential rights for the Compa-ny’s shareholders, subject to approval by the general meeting.

B.8 Selected key pro forma financial information

Not applicable. The prospectus contains no pro forma financial information.

B.9 Profit forecast or estimate

Not applicable. The prospectus contains no profit forecast or estimate.

B.10 Audit report qualifications

Not applicable. There are no qualifications in the audit reports pertaining to the historical financial information.

B.11 Insufficient working capital

It is Camurus’ assessment that the working capital is not sufficient for the present requirements during the next twelve months.

Camurus’ working capital requirements are mainly related to the continued development of the Com-pany’s product candidates and the establishment of a commercial organization for the sale of Buvidal® on selected markets in Europe and Australia. The working capital is deemed to be sufficient for financing Camurus’ operations until May 2019 and the shortfall in working capital for the next twelve months is expected to be somewhere in the range of SEK 300-350 million. The forthcoming rights issue is estimated to raise approximately SEK 403 million before transaction costs. Considering that the rights issue is fully underwritten through subscription and underwriting commitments from existing shareholders and external guarantors, the Board of Directors’ assessment is that the conditions for a fully subscribed rights issue are very good. However, the subscription and underwriting commitments are not secured.

If the rights issue, despite the abovementioned subscription and underwriting commitments, does not raise a capital contribution of at least SEK 403 million and if Camurus does not succeed to generate further revenues or to perform sufficient cost reductions, the Company may have to seek further external financing and postpone or terminate research and development activities. This can ultimately entail that the Group’s operations may have to be reduced.

SECTION C – SECURITIES

C.1 Securities offered/admitted to trading

Shares in Camurus (ISIN code SE0007692850).

C.2 Currency The currency of the shares in Camurus is SEK.

C.3 Number of shares issued

The Company’s registered share capital is SEK 959,537.15 as at the date of this prospectus, represented by 38,381,486 shares. All shares are fully paid. Each share has a quota value of SEK 0.025.


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C.4 Rights attached to the securities

Each share carries one vote at general meetings. Should the Company decide to issue shares, warrants or convertibles by way of a cash issue or a set-off issue (Sw. kvittningsemission), shareholders as a general rule shall have preferential rights to subscribe in proportion to their existing shareholdings. All shares carry the same right to dividend and any surplus in the event of liquidation. The right to receive dividends vests in holders recorded as owners of shares in the register of shareholders maintained by Euroclear Sweden on the record date for dividend established by the general meeting.

C.5 Restrictions on the free transferability

Not applicable. The shares are not subject to any restrictions on the free transferability.

C.6 Admission to trading

The new shares will be traded on Nasdaq Stockholm.

C.7 Dividend policy In accordance with the dividend policy adopted by the Board of Directors, Camurus will continue to focus on its strategy of developing and expanding the Company’s clinical project portfolio further and pursuing com-mercial operations, and the available financial resources will be utilized to finance this strategy. Consequently, the Board of Directors does not intend to propose any dividend to shareholders until Camurus generates sustainable profitability.

SECTION D – RISKS

D.1 Key risks specific to the issuer or its industry

An investment in securities is associated with risk. Prior to any investment decision, it is important to carefully analyze the risk factors considered to be of importance in relation to Camurus and the future performance of the shares. Set out below is a summary of the key risks specific to the industry and/or the operations:

• Pharmaceutical development and projects in early stages of development: Camurus’ projects require continued research and development, and are therefore subject to standard risks, such as the risks that product development may be delayed and that costs may be higher than expected or that the product candidates, at any stage of their development, may ultimately prove to be insufficiently effective or safe. The level of risk in the development of pharmaceuticals is generally high and a setback in any individual project could have a material adverse effect on Camurus.

• Technology platform with limited regulatory validation: Buvidal® is currently the only pharmaceutical product based on Camurus FluidCrystal® Injection depot which has achieved market approval. If product candidates based on this technology were to display shortcomings in safety or efficacy, there is a risk that Camurus or its partners are forced to discontinue further development and commercialization of product candidates, which could have a material adverse effect on Camurus.

• Clinical trials: Prior to launching a product candidate in the market, Camurus or its partners must carry out pre-clinical and clinical trials to document and prove that the product candidate has significant efficacy and an acceptable safety profile. The process usually require extensive, costly and time-con-suming pre-clinical and clinical trials. Clinical product development can be affected by unforeseen delays, increased costs, unforeseen suspensions and unfavourable results, which could have a material adverse effect on Camurus.

• Heavily dependent on the furthest advanced product candidates: Camurus is highly dependent on the continued success of the product candidates that are the furthest advanced in their development to market. Rejected applications for clinical trials or market approvals or assessments that the product candidates cannot be successfully commercialized could have serious adverse consequences for the Company. Camurus’ ability to finance its operations by receiving milestone payments and generating rev-enue from product sales is also dependent to a significant extent on the continuation of successful clinical development, grant of market authorization approvals and successful commercialization of these prod-ucts. Delays to or suspensions of these programmes could have a material adverse effect on Camurus.

• Product and technology collaborations with other pharmaceutical companies: Camurus is to a significant degree dependent on its collaborations regarding the development and commercialization of products. There is a risk that existing collaboration agreements will be terminated or that Camurus will be unsuccessful in entering into other such agreements in the future. Camurus’ ability to realize the value of its product candidates could be delayed or hindered by the absence of such partnership agreements. Furthermore, projects and collaborations can suffer delays for various reasons. The risks associated with out-licensing to other companies could delay, hinder or make the continued development or commercial-ization of the Company’s products more difficult, which could adversely affect Camurus.


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D.1 Key risks specific to the issuer or its industry (cont’d)

• Regulatory review and registration of new pharmaceuticals: A license or approval must be obtained from the relevant authorities in each country or region in order to commence and carry out clinical trials for or to market and sell a pharmaceutical product. Obtaining licenses and approvals can be time-consuming and can further delay, hinder or make the development and commercialization of a product more expen-sive. If the necessary license or registration is not obtained, is delayed or is associated with unexpected conditions, it will have an adverse impact on the ability to commence sales of the product, which in turn could have a material adverse effect on Camurus. The same applies if Camurus or its partners should not meet the applicable regulatory requirements and thereby become subject to various sanctions.

• Commercialization, market acceptance and dependence on reimbursement systems: If a phar-maceutical product obtains market approval, the risk remains it will not be commercially successful. The degree of market acceptance and sales of a drug depend on a number of factors, including product properties, clinical results, competing products, availability, price, reimbursement, sales and marketing efforts, prescribing physician awareness and clinical benefit outweighing side effects and other impacts of treatment. Realization of any of the risks related to the commercialization and sales of products and reimbursement systems could lead to an adverse effect on Camurus.

• Revenues from partners and licensees: A significant portion of Camurus’ revenues are expected to comprise revenues from collaboration partners and licensees. All such revenues are dependent on the successful development of the Company’s product candidates and the achievement of agreed develop-ment and regulatory milestones, and the subsequent product launch and sales in the market. If a collab-oration partner or licensee were to decide to discontinue the development of a product or end sales of a product Camurus’ revenues and financial position could be materially adversely affected.

• Patents and other intellectual property rights: There is a risk that existing and future patents and other intellectual property rights held by Camurus will not provide full commercial protection from infringement and competition. The patent position of pharmaceutical companies is generally uncertain and comprises complex assessments. There is a risk that the measures taken by Camurus to protect its intellectual prop-erty rights will not be sufficient. If Camurus is forced to defend its intellectual property rights, this could entail significant costs and delays to product development. There is also the risk that Camurus could unintentionally infringe another party’s intellectual property rights and thus become involved in court cases for alleged infringement of such other parties’ rights. Infringement disputes can have an adverse effect on Camurus’ operations, earnings and financial position.

D.3 Key risks specific to the securities

Set out below is a summary of the key risks specific to the shares and the rights issue.

• Share-related risks: Risk and risk taking is inevitably linked to shareholding. Since an investment in shares may increase or decrease in value, there is a risk that investors will not recover their invested capital.

• Future dividends: Camurus’ ability to pay future dividends is depending on the Group’s future results, financial position, cash flow, working capital requirements and other factors.

• Future sales of major shareholdings and new share issues: Future sales of major shareholdings and share issues could have an adverse effect on the share price.

• Significant influence for majority shareholder: Camurus’ largest shareholder, Sandberg Develop-ment, holds shares equivalent to 53.9 percent of the share capital and 53.9 percent of the votes in the Company. Sandberg Development can thus, both before and after the rights issue, exert a substantial influence over Camurus in matters that are subject to the approval of the shareholders.

SECTION E – OFFER

E.1 Net proceeds and expenses

Camurus will raise a maximum of SEK 403 million before transaction costs through the rights issue. The transaction costs to be deducted from the proceeds are estimated at approximately SEK 34 million (including fees to the underwriters of approximately SEK 8.9 million).

E.2a Reasons for the offer, use of proceeds

Since its initial public offering in December 2015, Camurus has continued the development of its clinical pipeline of own and partnered product candidates. Camurus’ product Buvidal® (CAM2038), weekly and monthly buprenorphine depots, for treatment of opioid dependence has successfully been through clinical Phase II and Phase III development and recently received approval in the EU and Australia, and tentative approval from the FDA in the US.

In November 2018, Buvidal® (CAM2038) was approved by the European Commission and the Australian Therapeutic Goods Administration as the first long-acting treatment of opioid dependence. This was a major achievement by the Company, which in January 2019 started the European roll-out of Buvidal® with launches in Finland, Sweden and the UK followed by launches in Germany and Denmark. The launches in Norway and Australia will be followed by the second wave’s important markets such as Italy, Spain, France and Israel.


S u m m A r y

E.2a Reasons for the offer, use of pro-ceeds (cont’d)

In December 2018, Camurus’ US partner Braeburn received a tentative approval of Brixadi™ (CAM2038) for the treatment of opioid use disorder from FDA. This decision lead to a delay in the milestone payment from Braeburn of USD 35 million, which will be triggered when final market approval is received from FDA. A final market approval for Brixadi™ monthly depot is according to the FDA related to the expiration of an exclusivity period granted to Sublocade™. The exclusivity period may not last longer than November 2020, but both the scope and duration could be reduced if successfully challenged by Braeburn. The weekly Brixadi™ product is not subject to the exclusivity and could therefore obtain a separate approval and launch earlier in the US.

Due to the delay of the aforementioned milestone payment from Braeburn, it is Camurus’ assessment that the working capital is not sufficient for the present requirements during the next twelve months. The shortfall in working capital for the next twelve months is expected to be somewhere in the range SEK 300-350 million. On this basis, the Board of Directors of Camurus has resolved on a rights issue with preferential rights for existing shareholders to continue to successfully deliver on the business plan and strategic objec-tives. The expected gross proceeds from the rights issue will, in the following priority and with an approxi-mate percentage in brackets, be used to:1. the launches and initial commercialization of Buvidal® for treatment of opioid dependence in Europe and

Australia (40-60 percent);2. continuing the planned development and perform Phase III studies of CAM2029 for the treatment of

acromegaly and neuroendocrine tumors (30-40 percent); and3. continuing building the Company’s pipeline and progressing prioritized R&D programs, including

CAM2043 for treatment of pulmonary arterial hypertension (“PAH”) (10-20 percent).

Net of transaction costs, Camurus is estimated to raise a maximum of approximately SEK 369 million through the rights issue.

E.3 Terms and condi-tions of the offer

On 6 February 2019, the Board of Directors of Camurus resolved, subject to approval by the General Meet-ing, to increase the Company’s share capital through a new share issue with preferential rights for the Com-pany’s shareholders. The Board of Directors’ resolution was approved by the Extraordinary General Meeting on 5 March 2019. The rights issue resolution entails that the Company’s share capital will increase by a maximum of SEK 239,884 through the issuance of not more than 9,595,372 new shares. The Company’s shareholders have preferential rights to subscribe for new shares in relation to the number of shares previ-ously held. The record date for participation in the rights issue is 7 March 2019. Those who are registered as shareholders of Camurus on the record date will receive one (1) subscription right for each share held on the record date, whereby four (4) subscription rights entitle to subscription of one (1) new share. To the extent that new shares are not subscribed for with preferential rights, they shall be allotted to shareholders and other investors who have subscribed for shares without preferential rights. Subscription shall take place during the period from 11 March 2019 up to and including 25 March 2019, or such later date as determined by the Board of Directors. The subscription price has been set at SEK 42 per share.

E.4 Interests material to the offer

Carnegie and Jefferies provide financial advice to Camurus in conjunction with the rights issue. From time to time, these advisors (and their affiliates) have provided, and may in the future provide, various banking, finan-cial, investment, commercial and other services to Camurus for which they have received, and may receive, compensation.

Seven larger shareholders in Camurus, together holding shares representing 69 percent of the total number of shares and votes in the Company, have undertaken in whole or in part to exercise their preferen-tial rights in the rights issue and thereby subscribe for new shares corresponding to in whole or in part their respective holdings in the Company. These subscription undertakings total approximately SEK 129 million, representing approximately 32 percent of the rights issue. In addition, a certain existing shareholders and certain other external investors have underwritten subscription for additional shares totaling SEK 190 million, corresponding to approximately 47 percent of the rights issue. The remaining approximately SEK 83 million of the rights issue is underwritten, subject to customary terms and conditions, by Joint Global Coordinators. Altogether, the subscription and underwriting commitments total 100 percent of the rights issue.

E.5 Person/entity offering to sell the security, lock-up agreements

Shareholders having entered into subscription undertakings (see E.4 above) have undertaken not to reduce their holdings in the Company up until the date the rights issue is fully registered by the Swedish Companies Registration Office.

E.6 Dilution The rights issue will, if fully subscribed, result in an increase of the number of shares in the Company from 38,381,486 to 47,976,858 shares, representing an increase of 25 percent. Shareholders who decline to subscribe for shares in the rights issue will experience a dilution with a total of 9,595,372 new shares, repre-senting approximately 20 percent of the total shares in the Company after the rights issue.

E.7 Expenses charged to the investor

Not applicable. The issuer will not impose any charges or taxes on investors.

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risk factors

An investment in securities is associated with risk. Prior to any investment decision, it is important to carefully analyze the risk factors considered to be of significance in relation to Camurus and the future performance of the shares. The risks currently considered to be of relevance to Camurus are described below, without being ranked in particular order of importance. There are risks both regarding circumstances linked to Camurus and/or the industry and those that are of a more general nature as well as risks associated with the shares and the new share issue. Some risks are beyond Camurus’ control. The description below does not purport to be complete and, for natural reasons, all risk factors cannot be predicted or described in detail. Therefore, an overall assessment must also include the other information in the prospectus, as well as a general assessment of extraneous factors. The below risks and uncertainty factors may have a material adverse effect on Camurus’ operations, financial position and/or results. They may also cause the shares in Camurus to decrease in value, which may result in Camurus’ shareholders losing all or part of their invested capital. Additional factors of which Camurus is currently unaware, or which currently are not deemed to be risks, may also have corresponding negative effects.

risks related to the industry and operationsPharmaceutical development and projects in early stages of developmentCamurus currently has, either itself or together with partners, about ten projects that are in clinical development phases and a number of projects in pre-clinical trials. These projects require continued research and development, and are therefore subject to standard risks related to pharmaceutical development, such as the risks that product development may be delayed and that costs may be higher than expected or that the product candidates, at any stage of their development, may ultimately prove to be insufficiently effective or safe. Any negative, unclear or insufficient results will increase the risk of Camurus not obtaining the necessary regulatory approvals and, if approved, may also make it more difficult for the Company to sell the products in the market or to enter into partnerships for the continued development, sale or distribution of the products. Accordingly, it may be difficult to evaluate and predict the time and cost aspects, and future sales potential, of any of the Company’s product candidates. The level of risk in the development of pharmaceuticals is generally high and a setback in any individual project could have a material adverse effect on Camurus’ operations and future revenue and thus Camurus’ financial position and earnings.

Technology platform with limited regulatory validationMost of the pharmaceutical product candidates being developed by Camurus, whether on a proprietary basis or in partnership with international pharmaceutical companies, are based on the Compa-ny’s lipid-based technology platform FluidCrystal® Injection depot, which can be used, for example, to extend the duration and release of pharmaceutical substances in the body. Buvidal® (CAM2038 for treatment of opioid dependence) is currently the only pharmaceutical product based on Camurus FluidCrystal® Injection depot which has achieved market approval. There is a risk that the Company’s other product candidates based on the Company’s Injection depot or its other technology platforms will be delayed to market or never reach it, and that in the future problems are identified that make it more

difficult for the Company to develop, or enter into partnerships for, additional product candidates with future commercial potential and value.

The long duration that characterizes pharmaceutical product can-didates based on Camurus’ Injection depot can potentially increase the risk of adverse events and other complications compared to if the drug compound were to be released immediately and work for a short time. If product candidates based on Camurus’ technology were to display shortcomings in safety or efficacy in ongoing or future clinical trials or in the market, there is a risk that Camurus or its part-ners decide, or are forced, to discontinue further development and commercialization of one or more product candidates based on this technology. This could have a material adverse effect on Camurus’ operations and ability to generate revenue and thus weaken Cam-urus’ financial position and future earnings.

Clinical trialsPrior to launching a product candidate in the market, Camurus or its partners must carry out pre-clinical and clinical trials to document and prove that the product candidate has significant efficacy and an acceptable safety profile. The process usually require extensive, costly and time-consuming pre-clinical and clinical trials. Positive results in previously completed pre-clinical and clinical trials do not guarantee positive results in later stages of development and subsequent clinical trials. Camurus is also unable to predict with any certainty when planned clinical trials can be started or when ongoing trials can be completed since there are numerous factors outside Camurus’ direct control that may impact this including, for exam-ple, the need for and timing of regulatory approvals and research ethics committee reviews, access to patients and clinical trial units, performing the clinical trial at the trial unit and the considerations of Camurus’ partners. It is also difficult to accurately predict the costs associated with clinical trials. Actual costs for carrying out any trial may significantly exceed estimated and budgeted costs. Clinical trials may also give rise to results that do not confirm the intended treatment efficacy or an acceptable safety profile due to undesirable side effects or an unfavorable risk-benefit assessment of the product candidate. This could lead to clinical trials being discontinued or cancelled, or the product not being granted the necessary regulatory approval for further clinical trials or sale in the market. In certain

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r I S k f A C T o r S

cases, the development program of the product candidate in ques-tion may need to be expanded with additional pre-clinical and/or clinical trials to enable market registration. In summary, clinical prod-uct development can be affected by unforeseen delays, increased costs, unforeseen suspensions and unfavorable results, which could have a material adverse effect on Camurus’ operations and ability to generate revenue from its projects and thus weaken Camurus’ financial position and future earnings.

Heavily dependent on the furthest advanced product candidatesTo date, Camurus has invested a significant portion of its human and financial resources in research and development of its product candi-dates that are the furthest advanced in their development to market, in particular Buvidal®/ Brixadi™ (which has achieved market approval in Europe and Australia), CAM2038 for chronic pain and CAM2029. Camurus is thus highly dependent on the continued success of these products and product candidates and on negative results not arising or negative decisions by authorities not being made on the continuation of product development. Examples of events that could have serious adverse consequences for the Company are rejected applications for clinical trials or market approvals for Camurus’ and its partners’ products, or assessments that the product candidates cannot be successfully commercialized due to other reasons. The same applies if a market approval is delayed or combined with restrictive conditions, as in the case with the tentative approval of Brixadi™ (monthly depot) from the US Food and Drug Administra-tion (“FDA”), in which a final approval from the FDA is related to the expiration of an exclusivity period granted by the FDA to a competing product.

Camurus’ ability to finance its operations by receiving milestone payments and generating revenue from product sales is also dependent to a significant extent on the continuation of successful clinical development, grant of market authorization approvals and successful commercialization of these furthest advanced products. Delays to or suspensions of these programmes can be expected to significantly reduce Camurus’ future revenue opportunities and thus also have material adverse effects on Camurus’ operations, financial position and earnings. Many of the risks associated with the contin-ued development and commercialization of the Company’s product candidates are also outside Camurus’ control (including, in addition to the need for successful clinical trials, receipt of required regulatory approvals and successful commercialization, other factors such as the absence of the launch of competing products). Also to the extent that development measures, clinical trials and market approvals are financed by Camurus’ partners, the above mentioned risks are relevant to Camurus.

If any of the risks described above would materialize, it could have an adverse effect on Camurus’ future earnings, operations and financial position.

Product and technology collaborations with other pharmaceutical companiesProduct and technology collaborations are key components of Cam-urus’ strategy for increasing its development capacity and commer-cial penetration, and for achieving profitability. An example of this is the Company’s collaboration with Braeburn for the development and commercialization of CAM2038 for treatment of opioid dependence and chronic pain, respectively, in North America. Camurus is to a significant degree dependent on its collaborations with Braeburn and other partners regarding the development and commercialization of the products under these collaborations. There is a risk that one or more of the Company’s existing collaboration agreements will be ter-

minated or that Camurus will be unsuccessful in entering into other such agreements in the future. Camurus’ ability to realize the value of its product candidates could be delayed or hindered by the absence of such partnership agreements. There is also a risk that differences of opinion will arise between Camurus and its partners or that such partners do not meet their contractual commitments. Furthermore, projects and collaborations can suffer delays for various reasons, something that is a common occurrence in pharmaceutical develop-ment since the schedules prepared when partnerships are entered into are indicative in nature. In addition, there is a risk that Camurus’ collaboration partners and licensees may prioritize the development of alternative products and product candidates that might also compete with the products and product candidates featured in their collaborations with Camurus. If this were to occur, it could reduce the ability and/or willingness of the Company’s collaboration partner or licensee to fulfil its obligations regarding the development and commercialization of the product candidates included in the collabo-ration with Camurus.

A licensing agreement typically provides that the partner takes over the main responsibility for the further development and com-mercialization of a product in a defined market. This is the case for CAM2038 in North America and certain other selected markets, which means that Camurus may have limited ability to exercise influence over the licensee’s or collaboration partner’s future devel-opment and commercialization activities. The risks associated with out-licensing to other companies could delay, hinder or make the continued development or commercialization of the Company’s products more difficult, which could adversely affect future revenue opportunities and thus have a material adverse effect on Camurus’ operations, financial position and earnings.

Regulatory review and registration of new pharmaceuticalsA license or approval must be obtained from the relevant authorities in each country or region in order to commence and carry out clinical trials for or to market and sell a pharmaceutical product. Various licenses and approvals are also required for the manufacture and distribution of a drug. Obtaining licenses and approvals can be time-consuming and can further delay, hinder or make the devel-opment and commercialization of a product more expensive, for example, due to differing opinions on which clinical trials are required for registration, including between the authorities of different coun-tries, or manufacturing not being deemed to meet the applicable requirements. Authorities may request additional information or make different assessments compared with Camurus and Camurus’ part-ners, e.g. regarding the interpretation of data from trials or the quality of data. Changes in authorities’ practices or procedures, as well as new or changed rules, may require additional work, entail that market approvals are delayed or ultimately result in the necessary license not being obtained or withdrawn. Regulatory authorities, e.g. in the US and the EU, may award orphan drug exclusivity to competing prod-ucts, which could delay market entrance in a corresponding indica-tion for Camurus’ products containing the same active pharmaceu-tical ingredient. In the US, part of the strategy for obtaining market approval for the Company’s product candidates is to apply to the FDA for approval via simplified drug approval pathways, for example 505(b)(2), which is based on utilizing existing and available data for the safety and efficacy of the active substance established for a ref-erence product. A similar approval pathway, called a hybrid applica-tion, is also applied by the EMA in the EU. The EMA’s decision on 22 november 2018 to grant market approval for Buvidal® in Europe was based on such hybrid application, and a simplified approval pathway is also applied in the ongoing approval process for Brixadi™ in the



US. The application of these simplified approval pathways, can also result in the scope of the pre-clinical and clinical registration programme being reduced for the Company’s other product candi-dates that are based on active substances where pre-existing data is available, as reference may be made to such data. However, if the authorities do not believe that the Company’s product candidates qualify for simplified approval pathways, additional clinical trials may need to be carried out to meet the requirements for market approval. This could mean that the development time is extended, that devel-opment costs become significantly higher and that development risk increases.

If the necessary licence or registration is not obtained, is delayed or is associated with unexpected conditions, it will have an adverse impact on the ability to commence sales of the product, which in turn could have a material adverse effect on Camurus’ ability to generate revenue and on Camurus’ financial position.

Camurus and its partners will be liable to meet certain regulatory requirements even after a product has been approved for marketing, including requirements for safety reporting and supervision of the marketing of the products. There is a risk of product side effects being manifested which have not been identified to the same extent in the earlier clinical trials. Furthermore, the Company’s manufacturer will be responsible for continuing to follow the rules that apply to the various stages of manufacturing, testing, quality control and documentation of the product in question. Production facilities will be regularly inspected by regulatory bodies, which could lead to obser-vations and new production requirements. If Camurus or its partners, including external manufacturers, do not meet the applicable regu-latory requirements, Camurus may be subject to fines, withdrawal of regulatory approval, recalls or seizure of products, other operational restrictions and criminal sanctions that could have material adverse effects on Camurus’ operations, financial position and earnings.

Handling narcotic substancesCAM2038 (including Buvidal® and Brixadi™) contains narcotics that are classified as “controlled substances” and therefore are subject to special regulatory rules, for example, regarding their production, handling, import and export. Failure on the part of Camurus, its collaboration partners, contract manufacturers or distributors to comply with these rules could result in administrative, civil or criminal sanctions that could have a material adverse effect on Camurus’ operations, financial position and earnings. Furthermore, it may also be difficult to find alternative manufacturers since the number of potential manufacturers holding the necessary regulatory licenses for producing these controlled substances may be limited.

Commercialization, market acceptance and dependence on reimbursement systemsIf a pharmaceutical product obtains market approval, the risk remains that sales, regionally or globally, may not meet expectations and that the product will not be commercially successful. The degree of market acceptance and sales of a drug depend on a number of factors, including product properties, clinical documentation and results, competing products, distribution channels, availability, price, reimbursement, sales and marketing efforts, prescribing physician awareness and clinical benefit outweighing side effects and other impacts of treatment, among other factors.

Sales of prescription drugs are influenced by the price set and obtained from the responsible authorities (such as the Dental and Pharmaceutical Benefits Agency in Sweden), from reimbursement payers and by healthcare payors, including insurance companies, hospitals and regionally responsible authorities. The reimbursement rate that, from time to time, applies for a pharmaceutical product

often depends on the value that the product is deemed to add for the patient, the healthcare system and the society as a whole. There is a risk that the products do not qualify for subsidies from privately and publicly financed healthcare programmes or that reimbursement is lower than expected, which among other things may affect the market acceptance of the product or the operating margin. Reimbursement systems may also change from time to time, making it more difficult to predict the benefit and reimbursement that a prescription product may obtain. Various initiatives are in place in many countries to curb rising pharmaceutical costs, which could affect future sales margins and product sales for Camurus and its partners. Such measures are expected to continue and could result in fewer reimbursement possibilities and lower reimbursement levels in certain markets.

Realization of any of the risks related to the commercialization and sales of products and reimbursement systems, most of which are beyond the Company’s control, could lead to an adverse effect on Camurus’ future revenues, operations, financial position and earnings.

CompetitionThe pharmaceutical industry is highly competitive and the product developments are characterized by significant innovation. Camurus’ competitors and potential competitors range from large multinational pharmaceutical companies, established biotech companies, special-ist pharmaceutical companies and generic companies, to universities and other research institutions. Several of Camurus’ competitors have significantly greater financial, technical and staffing resources, including research and development organizations, and more established manufacturing, distribution, sales and marketing organi-zations. As a result, these companies could potentially allocate more resources to carrying out clinical trials, obtaining market approval and launching, retailing and marketing their products. Furthermore, competition regarding individual products can be significant and competitors may develop and market drugs with higher efficacy, that are safer and/or less expensive than Camurus’ and its partners’ products, which could have an adverse effect on the competitive position of Camurus and its partners.

Several other companies have developed or are also developing drug delivery technologies for simplified pharmaceutical admin-istration or for extended release of active drug compounds in the human body that compete with or may compete with Camurus’ various technology platforms, such as the FluidCrystal® Injection depot. Camurus’ current and any future partners and customers may be evaluating and potentially develop such technologies them-selves. Rapid technological advancement could lead to competition heightening and intensifying, and to new drug delivery technologies with enhanced properties replacing or competing with Camurus’ technology as regards one or more pharmaceutical products in the market or product candidates under development, which could have an adverse effect on Camurus’ operations, financial position and earnings.

Revenues from partners and licenseesA significant portion of Camurus’ revenues are expected to comprise revenues from collaboration partners and licensees. These revenues may comprise milestone payments, which for example are depen-dent on the further development of product candidates, market approvals and future product sales, and sales-based royalties. All such revenues are dependent on the successful development of the Company’s product candidates and the achievement of agreed development and regulatory milestones, and the subsequent product launch and sales in the market. The level of future sales



of Camurus’ and its partners’ products, if any, is uncertain and will ultimately depend on a wide variety of factors, such as clinical results and marketing success. If a collaboration partner or licensee were to decide to discontinue the development of a product or end sales of a product – a decision over which Camurus can be expected to have no control – Camurus’ revenues and financial position could be materially adversely affected.

Dependence on suppliersCamurus and its partners engage and enter into agreements with external parties for parts of the product development activities including, for example, the production of pharmaceutical sub-stances, performance of clinical trials, certain laboratory services and manufacturing of commercial product. There is always the risk that such external parties do not perform their services satisfactorily, that delays occur or that a pharmaceutical substance does not meet quantitative or quality requirements. Other risks include the risk that a supplier fails to pass inspections from governmental authorities and loses its GMP license, or that a partner or an external party’s financial condition deteriorates. If this were to occur, continued product devel-opment could become more expensive, be delayed or be hampered, which could have an adverse effect on Camurus’ operations, finan-cial position and earnings.

The clinical trials being carried out on the Company’s product candidates require, and future sales of those product candidates will require, the production of active ingredients and other pharmaceuti-cal ingredients in both sufficient quantities and of the requisite quality. There is a risk that these requirements will not be met at a reasonable cost or at the planned point in time. The production processes are often complex and are also vulnerable to contamination, which can make the continued development of a product more expensive and could delay or hamper such development. In certain cases, only one or a small number of established manufacturers/suppliers of specialist ingredients included in the products based on Camurus’ drug delivery technology are available. Camurus may be dependent on such manufacturers, to the extent that their manufacturing processes conducted for the Company are complex and time-con-suming and thus challenging to transfer to another manufacturer. It could be costly and time-consuming if the need to change a man-ufacturer were to arise, and this could thus have a material adverse effect on Camurus’ operations, financial position and earnings. For future commercial requirements, the Company’s aim is that its critical ingredients and product manufacturing are to be provided by at least two manufacturers. There is a risk that it will not be possible to achieve this goal for all ingredients and products or that, even if two alternative sources are identified and engaged, that this still would not reduce Camurus’ dependence on individual manufacturers, to the extent desired.

Dependence on key personnel and qualified employeesCamurus is dependent on its qualified personnel in general and a number of key individuals, including all members of its management team, in particular. If a key individual were to leave the Company, this could have a short or long-term adverse effect on the Company’s projects and ability to successfully commercialize approved products and thus its operations, financial position and earnings. Camurus does not maintain any “key person” insurance in respect of any member of its senior management team. Camurus’ ability to retain and recruit qualified employees is of great importance to Camurus’ future success and growth potential and there is significant compe-tition from, for example, other industry companies, universities and other institutions. Any inability of Camurus to recruit or retain the

qualified employees that it needs to conduct its operations could have an adverse effect on the Company’s projects and thus its oper-ations, financial position and earnings.

Ability to manage growth and own commercializationA central part of Camurus’ business strategy is that the Company shall pursue commercialization of pharmaceutical products in selected markets in Europe and the rest of the world by itself as market approvals are obtained (just as the recent market approvals of Buvidal® in Europe and Australia). Since 2016 the Company is working on establishing an in-house sales and marketing orga-nization in certain selected markets in Europe and Australia, and Camurus’ organization has grown significantly since the Company was publicly listed in December 2015. Camurus has not previously pursued development of a similar commercial establishment or expansion of a marketing and sales organization inside or outside Europe.

There is a risk that the process of establishing an in-house sales and marketing organization will be more time-consuming and costly than the Company has estimated and that expected sales fail to materialize, completely or in part. In addition to company-specific and geographic risks (such as exposure to different and potentially overlapping legal systems and costs for compliance with such systems), the establishment and expansion of a new marketing and sales organization may entail increased demands on the Company’s management and on its operational and financial infrastructure. Camurus’ existing management resources, internal controls, gov-ernance structures, and accounting and information systems may prove to be insufficient for pursuing continued growth and additional investments in these areas may therefore be necessary. If Camurus proves to be unable to efficiently control or provide for continued growth, it could have an adverse effect on Camurus’ operations, financial position and earnings.

Increased exposure to macroeconomic factorsAs Camurus establishes and develops an in-house sales and marketing organization in certain selected markets in Europe and Australia, Camurus becomes more exposed than before to external macroeconomic factors, such as supply and demand, booms and recessions, inflation, interest-rate increases, exchange-rate fluctua-tions, trade barriers and other political decisions. Such external fac-tors may, among other things, have impacts on operating expenses, sales prices, the ability to acquire relevant raw materials and compo-nents, and the ability to market products in certain jurisdictions. Any of these factors could have an adverse effect on Camurus’ opera-tions, financial position and earnings.

Product liability and insuranceCamurus’ operations are subject to the risks of liability that are inher-ent for operations that carry out the research development, manu-facturing and sale of pharmaceutical products and medical devices. These include the risk of product liability claims that may arise in connection with the manufacturing, clinical trials and marketing and sale of pharmaceutical products and medical devices including, for example, clinical volunteers and patients suffering from side effects or being injured. Camurus normally tries to transfer a portion of its product liability risk to its partners and licensees, and takes out insurance to the extent that is commercially reasonable to cover risk of its own liability. There is nevertheless a risk that the Company’s applicable insurance policies or contractual regulations will not pro-vide sufficient coverage in the event of a potential claim for damages, which could have an adverse effect on Camurus’ operations, finan-cial position and earnings.



IT risksCamurus’ ability to effectively and securely manage and store proj-ect-related information, results and reports from its clinical trials, and other business-critical activities is dependent on its IT systems and related processes working efficiently and without interruption. Such systems can be disrupted by, for example, software and hardware problems, computer viruses, data intrusion, sabotage and physical damage. There is a risk that IT failure or other problems with IT sys-tems, depending on their length, scope and severity, could adversely affect Camurus’ operations, financial position and earnings.

Patents and other intellectual property rightsCamurus has an active intellectual property rights strategy, whereby the Company endeavors to protect its platform technologies and products in important global markets. There is a risk that existing and future patents, trademarks and other intellectual property rights held by Camurus will not provide full commercial protection from infringement and competition. The patent position of pharmaceutical companies is generally uncertain and comprises complex technical, medical and patent-law assessments. The pharmaceutical industry is also characterized by rapid technological advances and a high level of innovation. Accordingly, there is always the risk that new technologies and products are developed that could result in Cam-urus’ current and future intellectual property rights for technologies and products being circumvented or replaced. Patents are, by their nature, limited in time. The patents of other companies can also limit opportunities for Camurus or its collaboration partners and licensees to freely use a certain product or production method. Since patent applications are confidential until they are published, there is the risk that Camurus’ patent applications may not be prioritized in relation to previously unknown patent applications and patents. Furthermore, it is not certain that Camurus’ patent applications will result in patents being granted or that any patent protection granted will have the same scope as was stated in the original application. There is a risk that granted patents will be declared null and void, for example, as a result of a dispute with a third party. Under the Company’s licensing agreements, Camurus’ partners may be granted certain rights to Camurus’ patents that encompass the products included in the agreement and Camurus may be granted certain rights in patents granted to Camurus’ partners. As a result, these patents are not always or fully under Camurus’ direct control. For example, the future sales of Brixadi™ in the US is partly dependent on Braeburn’s ability to renew and maintain the patents it has licensed from Camurus. If Camurus’ partners fail in this respect, it could have a material adverse effect on Camurus’ ability to generate revenue.

Furthermore, there is a risk that the measures adopted by Camurus in order to protect its patents, trademarks and other intel-lectual property rights will not be successful or sufficient and that competitors and others may, intentionally or unintentionally, infringe Camurus’ patents, trademarks or other intellectual property rights. Laws and practice regarding the protection of intellectual property rights vary extensively between countries and Camurus’ rights may thus be more vulnerable in some countries than in others. If Camurus is forced to defend its patents, trademarks and other intellectual property rights, this could entail significant costs and delays to product development. There is also the risk that Camurus could unintentionally infringe another party’s intellectual property rights and thus become involved in court cases for alleged infringement of such other parties’ rights. Companies may also be subjected to baseless lawsuits regarding patent infringement. Infringement disputes can, similar to other types of disputes, be costly and time-consuming and thus could have an adverse effect on Camurus’ operations, earnings and financial position.

Know-how and trade secretsCamurus is dependent on know-how and trade secrets, which are not protected by registration in the same way as other intellectual property. To protect its know-how, Camurus uses, for example, con-fidentiality agreements, but unauthorized disclosure or unauthorized use of Company information – by competitors, business partners, consultants or employees, among others – could still occur. There is also a risk that competitors and others could independently develop similar know-how, which could be detrimental to Camurus’ opera-tions, financial position and earnings.

Share dealing investigationOn 1 June 2018, Camurus was contacted by Nasdaq Stockholm in connection with a press release issued by the Company on 31 May 2018 regarding clinical Phase I results for a long-acting treprostinil for the treatment of pulmonary arterial hypertension. Nasdaq Stockholm later decided to initiate an investigation on whether the Company’s disclosure of information was in compliance with applicable insider regulations. Nasdaq Stockholm has subsequently closed its investi-gation without further action and has, in accordance with applicable rules, handed over the case to the Swedish Financial Supervisory Authority. Although Nasdaq Stockholm has closed its investigation without further action, there is a risk that the Swedish Financial Supervisory Authority or any other authority will take action against the Company resulting in financial or other types of sanctions that could have an adverse effect on the Company’s operations, financial position and earnings.

Disputes and legal proceedings Camurus may from time to time be the subject of legal proceedings related to its operating activities. Such legal proceedings, in addition to the disputes referred to above regarding intellectual property infringement and validity of certain patents, may also include com-mercial disputes. Disputes and claims can be time-consuming, disrupt operations, involve considerable sums or principally import-ant issues and entail significant costs, and thus adversely affect the Company’s operations, earnings and financial position.

Tax risksCamurus conducts operations involving several countries, including in Sweden where Camurus’ headquarter is located, and in Germany, the UK, France, Norway, Finland, Denmark and Australia, where Camurus is establishing local commercial organizations for the product launch of Buvidal®. As far as Camurus is aware, it conducts its operations in compliance with applicable tax laws in Sweden as well as abroad, including Camurus’ intra-group transactions. There is, however, a risk that Camurus’ interpretation of these tax rules may be incorrect or that the laws may change, possibly with retroactive effect. As a result of decisions by Swedish and foreign tax authorities, Camurus’ previous or current tax situation could therefore change, which could have an adverse effect on Camurus’ operations, earn-ings and financial position.

Furthermore, as a result of the collaboration and licensing agree-ments that Camurus has entered into, the Company must make complicated assessments relating, inter alia, to revenue recognition. Important assessments include whether an agreement should be divided into different sub-transactions, how to allocate the price of these transactions, how the timing of the transactions should be reported and in what way (on one occasion or over time). Camurus must also determine whether a collaboration and license agreement should be recognized as revenue upon delivery, or if the agreement involves a lease agreement to be recognized as revenue over time.



Further, Camurus’ management team makes judgments and estimates regarding the possibility of utilizing incurred losses for tax deductions. If the Company in the future will not generate profit in line with the Company’s current expectations, or not at all, Camurus will not be able to offset incurred losses as estimated, which may result in an increased tax burden for the Company. Correspondingly, changes in applicable tax rates, or other governmental tax policy decisions, may adversely affect the Company’s tax position.

Corporate governance and CSR risksCamurus is subject to the risk that executives may make decisions that are not consistent with Camurus’ strategies, internal guidelines and policy documents, a risk which may increase as the Company continues its geographical and organizational expansion. Further-more, employees within Camurus and other persons related to Camurus, as well as its partners, may perform acts that are consid-ered unethical, are criminal (e.g. violation of applicable bribery and anti-corruption legislation) or otherwise contrary to applicable laws and regulations or Camurus’ internal guidelines and policy docu-ments. If Camurus’ internal controls and other measures to ensure compliance with laws, regulations, internal guidelines and policy documents prove to be insufficient, Camurus’ reputation may be tarnished or the Company may be affected by public law sanctions, which could result in an adverse effect on its operations, financial position and earnings.

Operating losses and additional financing needsWith the exception of the 2012-2014 financial years, Camurus has reported operating losses since the Company’s operations started, and cash flow is expected to remain neutral or negative until such time as Camurus can generate annual revenues from products in the market. It is Camurus’ assessment that the existing working capital is not sufficient for the present requirements during the next twelve months. Going forward, Camurus will continue to require significant capital for continuing research and development of poten-tial products. Both the extent and timing of Camurus’ future capital requirements will depend on a number of factors, such as costs for its operations and its ongoing geographical and organizational expansion for the commercialization of Buvidal® on selected markets in Europe and Australia, the potential success of its research and development projects and opportunities for entering into partnership and licensing agreements, the timing for the receipt and amount of milestone payments and royalties, the timing of market approval and the market reception of potential products. Access to and the terms and conditions for additional financing are influenced by several factors, such as market conditions, the general availability of equity and debt financing and Camurus’ attractiveness as an investment and/or the Company’s credit rating and credit capacity. Turmoil and uncertainty in the credit and capital markets can also limit access to additional financing. If the Company chooses to obtain additional financing by issuing shares or share-based instruments, the Com-pany’s shareholders who do not or may not participate will have their holdings diluted, while debt financing, if available to the Company, may contain terms and conditions that restrict the Company’s oper-ational and financial flexibility. There is a risk that new capital cannot be obtained when needs arise, that capital cannot be obtained on favorable terms or that no capital at all can be raised. If Camurus is unable to obtain financing as required, the Company may be required to significantly curtail one or more of its research or develop-ment programmes or ultimately discontinue operations.

Exchange rate riskCamurus is exposed to foreign exchange risk in the form of transac-tion exposure. Camurus is based in Sweden and reports its financial position and results in SEK. Transaction exposure arises from the purchase and sale of goods and services in currencies other than SEK. A large portion of Camurus’ revenues and expenses are, and are expected in the future to remain, denominated in foreign currencies, principally EUR, USD and GBP. Camurus’ finance policy allows hedging instruments to be used, but if Camurus’ measures to address the impact of exchange rate fluctuations do not prove to be sufficiently effective, Camurus’ financial position and earnings could be adversely affected. Currently, no hedging instruments are being used by Camurus.

Credit riskCredit risk refers to the risk that Camurus’ counterparties cannot meet their payment obligations and thereby create a loss for Cam-urus. For example, there is a risk that Camurus’ collaboration part-ners and licensees are not able to satisfy their payment obligations for milestones and potential future royalties as they fall due, or that potential future customers (such as wholesalers and pharmacies) are not able pay for their purchases on time or at all. If Camurus’ mea-sures to manage credit risk are inadequate, this may adversely affect Camurus’ financial position and earnings.

Changes in accounting rulesThe Group is affected by the accounting rules applicable from time to time in the jurisdictions in which the Company operates, for example International Financial Reporting Standards (“IFRS”) pursuant to which Camurus prepares its consolidated financial statements. In the future, Camurus’ accounting, financial reporting and internal control may be affected by, and have to adapt to, changes in accounting rules or changes in the application and interpretation of such accounting rules.

When preparing an annual report in accordance with IFRS, the Group Management and the Board of Directors have to make esti-mates, assessments and assumptions that affects the application of accounting principles and assets, debts, revenues and costs accounted for. However, the actual result may deviate from these estimates and assessments. IFRS are updated regularly by the International Accounting Standards Board (“IASB”) and approved by the EU. Such updates and approvals may entail that Camurus has to make further and more extensive estimates and assessments when preparing Camurus’ financial reports in accordance with IFRS. In addition, changes in accounting rules or changes in the application and interpretation of such accounting rules may lead to uncertainty as regards Camurus’ accounting, financial reporting and internal control and may affect Camurus’ reported revenues, balance sheet and equity, which may have a material adverse effect on Camurus’ earnings and financial position.

A recent example is IFRS 16 (Leases), which has replaced IAS 17, which shall be applied for financial years beginning 1 January 2019. Any transitional effects resulting from the implementation of changes in accounting rules or in the application and interpretation of such rules may affect the Group’s reported earnings, balance sheet and equity, which may have a negative impact on Camurus’ financial position and results.



risks related to the sharesShare-related risksRisks and risk-taking are inevitable aspects of owning shares. Since a share investment can both rise and fall in value, there is a risk that an investor will not recover the capital invested. The share price for listed companies can be very volatile and its development is depen-dent on a number of factors, some of which are company-specific while others are tied to the stock market as a whole. It is impossible for an individual company to control all of the factors that may affect its share price, and consequently any investment in shares should be preceded by a careful analysis.

There is a risk that the liquidity and price of the shares are subject to large fluctuations in response to general economic conditions or fluctuations in the stock market in general. Such fluctuations can occur regardless of how Camurus actually performs or the condi-tions in its main markets and may adversely affect the liquidity and price of the shares. Further, the trading market for the shares in Cam-urus will be influenced by the research and reports that securities or industry analysts publish about the Company (if any). If one or more of the analysts who cover the Company, or the industry in which it operates, downgrades the Company’s shares, the market price of the shares may decline. If one or more of these analysts ceases coverage of the Company or fails to regularly publish reports on the Company, the Company could lose visibility in the financial and share markets, which could cause the market price or trading volume of the Company’s shares to decline.

Trading in subscription rights and paid subscribed shares (BTA)Persons who are registered as shareholders in Camurus on the record date receive subscription rights in proportion to their existing shareholdings. The subscription rights are expected to have an economic value that can only benefit the holder if he or she either exercises them to subscribe for new shares no later than 25 March 2019 or sells them no later than 21 March 2019. After 25 March 2019, unexercised subscription rights will be removed, without prior notification, from the holders’ securities account and the holder will thus be deprived of the expected economic value of the subscription rights. Both subscription rights and BTA that, after payment, are booked into the securities accounts of those who subscribed for new shares, will be subject to trading on Nasdaq Stockholm for a limited period of time. Trading volumes in these instruments may be limited, which may cause problems to individual holders in selling their subscription rights and/or BTA. Limited liquidity could also enhance fluctuations in the market price of subscription rights and/or BTA. Accordingly, pricing of these instruments could be incorrect or misleading.

DilutionHolders of shares who do not participate in the rights issue before the expiration date of the subscription period will lose their rights to subscribe for new shares at the subscription price, and no com-pensation will be paid to holders whose rights lapse as a result of a failure to exercise or sell their subscription rights. Holders of shares who do not exercise their subscription rights or only partially exercise their subscription rights, or who cannot exercise subscription rights because of applicable legal restrictions, will experience dilution of their proportional holdings of shares and votes in Camurus.

Unsecured subscription and underwriting commitmentsCertain larger shareholders in Camurus have undertaken to sub-scribe for around 32 percent of the rights issue in total. The remain-

der of the rights issue is underwritten by certain existing shareholders and certain other external investors as well as by the Joint Global Coordinators. These subscription and underwriting commitments are not secured. Consequently, there is a risk that one or more of the shareholders or guarantors will not be able to meet their respective underwriting or subscription commitments. If the abovementioned commitments are not met, this could negatively impact Camurus’ ability to successfully complete the rights issue.

Future dividends Historically, no dividend has been paid by Camurus and the intention is to not propose dividends to the shareholders unless and until Camurus achieves long-term profitability. Hence, there is a risk that no dividends will ever be paid in the future. The size of future dividends, if any, will depend on Camurus’ future earnings, financial position, cash flows, working capital requirements and other factors.

Significant influence for majority shareholderCamurus largest shareholder Sandberg Development AB (“Sand-berg Development”) holds 53.2 percent of the shares and votes in the Company. This means that Sandberg Development has a signifi-cant influence over Camurus and most resolutions that are subject to voting at the general meeting. This will presumably be the case even if Sandberg Development’s relative ownership in Camurus would be reduced due to Sandberg Development not fully exercising its prefer-ential right. Such matters include the election of board members, the issuance of additional shares and share-related securities that could entail dilution for existing shareholders and resolutions on dividends, if any. There is a risk that Sandberg Development’s interests may differ or be contrary to the interests of other shareholders.

Future sales of major shareholdings and new share issues Substantial sales of shares by major shareholders, including Sand-berg Development, as well as a general market expectation that additional sales of shares may or will be made, may affect Camurus’ share price negatively. Moreover, new share issues would lead to a dilution of the ownership of shareholders who for some reason are unable to participate in such a new issue or do not choose to exercise their right to subscribe for shares. The same risk of dilution applies in the event that new shares are issued in an offering directed at other than existing shareholders.

Specific risks for foreign shareholdersCamurus’ shares is quoted in SEK and any dividends will be paid in SEK. This means that shareholders outside Sweden may be negatively impacted on the value of their holdings of shares and div-idends, if any, when these are translated into other currencies if the SEK decreases in value against the currency concerned.

If, in the future, Camurus issues new shares with preferential rights for existing shareholders, shareholders in certain countries may be subject to limitations preventing them from participating in such new share issues or otherwise impeding or limiting their partic-ipation. For example, shareholders in the United States may be pre-vented from exercising such preferential subscription rights unless an exemption from the registration requirements of the Securities Act is applicable. Shareholders in other jurisdictions outside Sweden may also be affected in a similar manner depending on local legal require-ments. To the extent that shareholders in jurisdictions other than Sweden are unable to subscribe for new shares in any rights issues, their proportionate ownership in Camurus will decrease.


Invitation to subscribe for shares in Camurus

1) Transaction cost estimated at approximately SEK 34 million (including fees to the underwriters of approximately SEK 8.9 million) will be deducted from the rights issue proceeds of not more than SEK 403 million. Net of transaction costs, Camurus is estimated to raise a maximum of approximately SEK 369 million through the rights issue.

2) See also “Subscription and underwriting commitments” in “Legal considerations and supplementary information”.3) The subscription and underwriting commitments are not secured, see “Unsecured subscription and underwriting commitments” in “Risk factors”.

On 6 February 2019, the Board of Directors of Camurus resolved, subject to approval by the general meeting, to increase the Company’s share capital through a new share issue with preferential rights for Camurus’ shareholders. The Board of Directors’ resolution was approved by the Extraordinary general meeting on 5 March 2019.

The rights issue resolution entails that the Company’s share capital will increase by a maximum of SEK 239,884 through the issuance of not more than 9,595,372 new shares. The Company’s shareholders have preferential rights to subscribe for new shares in relation to the number of shares previously held. The record date for participation in the rights issue is 7 March 2019. Those who are registered as shareholders of Camurus on the record date will receive one (1) subscription right for each share held on the record date, whereby four (4) subscription rights entitle to subscription of one (1) new share. To the extent that new shares are not subscribed for with preferential rights, they shall be allotted to shareholders and other investors who have subscribed for shares without preferential rights in accordance with the principles set out in “Terms and conditions”. Such allotment shall firstly be made to those who have also subscribed for shares by exercise of subscription rights. Subscription shall take place during the period from 11 March 2019 up to and including 25 March 2019, or such later date as determined by the Board of Directors, and otherwise in accordance with the instructions included in “Terms and conditions”.

The subscription price has been set at SEK 42 per share. Provided that the rights issue is fully subscribed, Camurus will consequently raise in total SEK 403 million before transaction costs.1)

Shareholders who elect not to participate in the rights issue will have their holdings diluted by up to approximately 20 percent, but have the possibility to compensate themselves financially for the dilution by selling their subscription rights.

Subscription and underwriting commitments2) Camurus’ largest shareholder, Sandberg Development, holding approximately 53 percent of the Company’s outstanding shares, and the Company’s President and CEO Fredrik Tiberg, holding approximately 4 percent of the outstanding shares, have committed to subscribe for SEK 75 million and SEK 5 million, respectively, in the rights issue. Furthermore, existing shareholders Gladiator, the Fourth Swedish National Pension Fund, Backahill Utveckling, Grenspecialisten Förvaltning and Maven Investment Partners, together holding approximately 12 percent of the outstanding shares, have committed to subscribe for their pro rata shares of the rights issue. In aggregate, these subscription undertak-ings total approximately SEK 130 million, representing approximately 32 percent of the rights issue.

In addition, certain existing shareholders, including Gladiator, the Fourth Swedish National Pension Fund, Grenspecialisten Förvaltning and Maven Investment Partners, and certain other external investors, including LMK Venture Partners and CVI Investments Inc. (through Heights Capital Management), have committed to subscribe for and underwrite an additional SEK 190 million in total, representing approximately 47 percent of the rights issue. The remaining approximately SEK 83 million of the rights issue is underwritten, subject to customary terms and conditions, by the Joint Global Coordinators.3) The rights issue is thus fully underwritten. Also, Enter Fonder and Swedbank Robur Fonder, together holding approximately 3 percent of the outstanding shares, have indicated that they are positive to the rights issue and that they intend to subscribe for their pro rata shares of the rights issue.

The shareholders of Camurus are hereby invited to subscribe for new shares in Camurus with preferential rights in accordance with the terms and conditions of this prospectus.

Lund, 7 March 2019

Camurus AB (publ)The Board of Directors


Background and reasons

Camurus is a Swedish research-based pharmaceutical company committed to developing and commercialising innovative and differentiated medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the proprietary FluidCrystal® drug delivery technologies and an extensive R&D expertise. Camurus’ clinical pipeline includes products for treatment of cancer, endocrine diseases, pain and addiction, developed in-house and in collaboration with international pharmaceutical companies.

Since its initial public offering in December 2015, Camurus has continued the development of its clinical pipeline of own and partnered product candidates. Camurus’ product Buvidal® (CAM2038), weekly and monthly buprenorphine depots, for treatment of opioid dependence has successfully been through clinical Phase II and Phase III development and recently received approval in the EU and Australia, and tentative approval from the FDA in the US.

In November 2018, Buvidal® (CAM2038) was approved by the European Commission and the Australian Therapeutic Goods Administra-tion as the first long-acting treatment of opioid dependence. This was a major achievement by the Company, which in January 2019 started the European roll-out of Buvidal® with launches in Finland, Sweden and the UK followed by launches in Germany and Denmark. The launches in Norway and Australia will be followed by the second wave’s important markets such as Italy, Spain, France and Israel.

In December 2018, Camurus’ US partner Braeburn received a tentative approval of Brixadi™ (CAM2038) for the treatment of opioid use disorder from FDA. This decision lead to a delay in the milestone payment from Braeburn of USD 35 million, which will be triggered when final market approval is received from FDA. A final market approval for Brixadi™ monthly depot is according to the FDA related to the expiration of an exclusivity period granted to Sublocade™. The exclusivity period may not last longer than November 2020, but both the scope and duration could be reduced if successfully challenged by Braeburn. The weekly Brixadi™ product is not subject to the exclusivity and could therefore obtain a separate approval and launch earlier in the US.

Since 2016, Camurus has invested significant resources in building a commercial infrastructure and organization for commercializing Buvidal® in Europe and Australia. Experienced marketing and sales teams and effective distribution models are now in place in all wave one markets in Europe and Australia.

Due to the delay of the aforementioned milestone payment from Braeburn, it is Camurus’ assessment that the working capital is not suffi-cient for the present requirements during the next twelve months. The shortfall in working capital for the next twelve months is expected to be somewhere in the range SEK 300-350 million. On this basis, the Board of Directors of Camurus has resolved on a rights issue with preferential rights for existing shareholders to continue to successfully deliver on the business plan and strategic objectives. The expected gross proceeds from the rights issue will, in the following priority and with an approximate percentage in brackets, be used to:

1. the launches and initial commercialization of Buvidal® for treatment of opioid dependence in Europe and Australia (40-60 percent);2. continuing the planned development and perform Phase III studies of CAM2029 for the treatment of acromegaly and neuroendocrine

tumors (30-40 percent); and3. continuing building the Company’s pipeline and progressing prioritized R&D programs, including CAM2043 for treatment of pulmonary

arterial hypertension (“PAH”) (10-20 percent).

If the rights issue, despite the subscription and underwriting commitments made, does not raise a capital contribution of at least SEK 403 million and if Camurus does not succeed to generate further revenues or to perform sufficient cost reductions, the Company may have to seek further external financing and postpone or terminate research and development activities. This can ultimately entail that the Group’s operations may have to be reduced.

The Board of Directors of Camurus is responsible for the contents of this prospectus. The Board of Directors hereby declares that, having taken all reasonable care to ensure that such is the case, the information in this prospectus is, to the best of the Board of Directors’ knowl-edge, in accordance with the facts and contains no omissions likely to affect its import.

Lund, 7 March 2019

Camurus AB (publ)The Board of Directors

I N V I TAT I O N T O S U B S C R I B E F O R S H A R E S I N C A M U R U S A B

B A C k g r o u n d A n d r e A S o n S


Business description and market overview

1) IMS Institute for Healthcare Informatics, Outlook for Global Medicines, December 2016.2) IMS Institute for Healthcare Informatics, Outlook for Global Medicines, December 2016.3) Pharma 2020: Challenging business models. Which path will you take? PricewaterhouseCoopers.

Camurus in briefCamurus is a Swedish science-led, commercial-stage biopharma-ceutical company committed to developing and commercializing innovative and differentiated medicines for the treatment of severe and chronic conditions. New pharmaceutical products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal® technologies and its extensive research and develop-ment (R&D) expertise. Camurus’ clinical pipeline includes innovative therapeutics for the treatment of opioid dependence, chronic pain, neuroendocrine tumors, acromegaly and genetic obesity, developed in-house and in collaboration with international pharmaceutical companies.

Operations comprise all areas ranging from R&D, manufacturing and distribution to marketing and sales. Camurus has decades of experience in research and pharmaceutical development, and many of its employees are pioneers in the field of lipid-based drug delivery and co-inventors of the company’s proprietary FluidCrystal® technol-ogy. The commercial organization is led by an international team with extensive experience from marketing and sales of specialty pharma-ceuticals in areas of opioid dependence, pain and endocrinology.

Camurus’ commercial infrastructure is well developed in Europe and Australia, with subsidiaries established in Germany, the UK, France, Finland, Denmark, Norway and Australia for the launch of Buvidal® for the treatment of opioid dependence. Camurus has entered into strategic partnerships for the registration and commer-cialization of Buvidal® in the US and Israel and intends to continue building its network of distributors outside Europe and Australia. The company plans to expand its commercial operations over time and market additional products originating from its own proprietary devel-opment pipeline and through new licenses, distribution agreements and acquisitions.

Camurus’ ability to develop innovative treatments from initial concept to approved medicine was recently demonstrated with the approval of weekly and monthly Buvidal® by the European and Aus-tralian health authorities, and by the tentative approval of the same product under the trade name Brixadi™ in the US. The inflow of new projects from in-house research is complemented by collaborations with international biotech and pharmaceutical partners as well as with academia. Camurus also actively pursues business coopera-tion, in-licensing and acquisitions.

Camurus’ organization has grown significantly since 2015. As of 31 January 2019, the company had 100 employees, divided between the Company’s headquarter in Lund, Sweden and com-mercial subsidiaries in Europe and Australia.

The pharmaceutical market: an overviewGeneral growth trendsThe global pharmaceutical market is expected to reach nearly 1.3 trillion USD by 2021, representing an increase of 370 billion USD from 2016.1) The US will continue as the world’s largest pharmaceuti-

cal market, followed by Japan – which replaced China as the second largest pharmaceutical spending country in 2012. The growth in developed markets will be driven by original brands, while generic products are dominating in emerging markets with on average 91% of market volume and 78% of spending.2) Of all new medicines, spe-cialty medicines will increase their share reaching nearly half of total spending in the US and European markets. This rise will be driven by the adoption of new breakthrough medicines and is constrained by cost and access controls and a greater focus on assessments of value.

The role of R&D companies Historically, large pharmaceutical companies have undertaken the entire development process in-house, from R&D to commercial-ization.3) However, the major pharmaceutical companies are now increasingly dependent on collaboration with smaller research-ori-ented biopharmaceutical companies that conduct early-stage proj-ects and then license their product candidates to larger companies with the capacity to conduct major clinical trials and commercialize the products on the global market. These joint ventures can stream-line product development from idea to market and reduce risks and costs for both parties. Licensing agreements for new product candidates often entitle the R&D company to down payments, mile-stone payments and royalties. Such agreements also usually include collaborations, in which employees from both sides are involved in the product development. Other typical agreement factors may be joint marketing and sales, or exclusive rights in certain markets. Technology-related agreements may cover multiple future product candidates.

Camurus’ product portfolioCamurus invests significant resources in the R&D of its proprietary drug delivery technologies and product candidates for the treatment of serious and chronic conditions. New innovative medicines with improved properties and treatment outcomes are conceived by combining the company’s patented drug delivery technologies with active pharmaceutical ingredients with documented safety and efficacy profiles. These may be developed with significantly lower costs and risks, compared with the development of completely new pharmaceuticals.

Camurus’ current pipeline of product candidates is shown in the figure below. This includes Buvidal® (weekly and monthly buprenor-phine depots), which was recently approved in the EU and Australia for the treatment of opioid dependence. The company’s develop-ment pipeline contains product candidates across different indication areas, including opioid dependence, pain, oncology and oncology supportive care, endocrinology, cardiovascular diseases and obesity.


B u S I n e S S d e S C r I p T I o n A n d m A r k e T o v e r v I e w

These innovative product candidates are either fully-owned and developed by Camurus or out-licensed to a partner, as in the case of Brixadi™ (the US trade name of Buvidal®), where Camurus’ partner

Braeburn has obtained the rights to develop and commercialize Brixadi™ under a license agreement signed with Camurus in 2014.

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PRODUCT PRECLINICAL PHASE 1-2 PHASE 3 REGISTRATION MARKETBuvidal® (CAM2038) q1w OPIOID DEPENDENCE APPROVED

Buvidal® (CAM2038) q4w OPIOID DEPENDENCE APPROVED

CAM2038 q1w CHRONIC PAIN1 PHASE 3

CAM2038 q4w CHRONIC PAIN1 PHASE 3

CAM2029 ACROMEGALY PHASE 1-2

CAM2029 NEUROENDOCRINE TUMORS PHASE 1-2

CAM2032 PROSTATE CANCER PHASE 1-2

CAM4072 GENETIC OBESITY DISORDERS2 PHASE 1-2

CAM2043 PULMONARY ARTERIAL HYPERTENSION PHASE 1-2

Brixadi® (CAM2038) q1w OPIOID DEPENDENCE1 TENTATIVELY APPROVED

Brixadi® (CAM2038) q4w OPIOID DEPENDENCE1 TENTATIVELY APPROVED

CAM2047 CINV3 PHASE 1-2

CAM2048/58 POSTOPERATIVE PAIN & PONV1,4 PHASE 1-2

1. Braeburn holds the rights to North America; 2. Developed by Rhythm Pharmaceuticals under a worldwide license to Fluid Crystal®; 3. Postoperative nausea and vomiting.

Camurus also has several early-stage product candidates in preclin-ical development with the potential to enter into clinical development within the coming years, addressing significant unmet medical needs within different market segments.

Based on its unique FluidCrystal® technologies, Camurus is also engaged in R&D collaborations with international biotech and phar-maceutical companies aiming at the development of new medicines or life-cycle management of existing products. In addition to project revenues, these collaborations may result in future licenses with potential for significant revenues in the forms of milestone payments and royalties on sales.

Camurus has also developed the medical device product episil® oral liquid for the management and treatment of pain in the oral cavity. episil® adheres to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis, a common and debilitating side effect of chemo and radiotherapy. The product has received market authorization and has been launched in several markets, including the EU, US, Japan and China. Sales and distri-bution of episil® are mainly conducted through partners, although Camurus sells the product in Sweden, Denmark and the UK.

Camurus’ historyCamurus was founded in Lund, Sweden in 1991 by a group of lead-ing scientists in physical and biophysical chemistry at Lund University

and Lund Institute of Technology. As pioneers in the areas of lipid self-assembly, phase behavior and nanostructure formation, and being aware of the significant drug delivery challenges in pharmaceu-tical development, Camurus started as a provider of early stage R&D services and out-licensing of IP rights.

Initially, Camurus followed a service-based approach, in which the company was active in R&D projects for other companies. One such collaboration, with the Danish company Dumex-Alpharma, led to the first registered product, Elyzol® dental gel. Elyzol® was approved in Europe for the treatment of periodontitis, and later licensed to Colgate Oral Pharmaceuticals. Camurus also collabo-rated with a range of industrial partners but did not pursue its own clinical-stage product development.

In 2004, after new research, scientific innovations and the development of innovative lipid formulation technologies, Camurus instigated a new strategic direction and began the development of its proprietary FluidCrystal® technology and novel product candidates. Based on these initiatives, Camurus has now developed what the company considers to be a leading position in lipid-based drug formulations and created a broad and diversified pipeline of clini-cal-stage product candidates, developed in-house or in partnership with leading international pharmaceutical companies. A brief history of the company is presented below.

4

Major milestones in Camurus’ history

1991 • Camurus incorporated

2004 • New business strategy‒ Investment in own pharmaceutical

products pipeline2005 • First patent applications for FluidCrystal® injection

depot platform

2007 • Positive results from first clinical study of FluidCrystal® injection depot (CAM2029)

2009 • Start first clinical trial of CAM2038

2011 • Collaboration, option and license agreementsigned with Novartis

2019 • Launch of Buvidal® in the EU

2018 • Buvidal® approved in the EU and Australia• Tentative approval for Brixadi™ in the US• Novartis returns rights to CAM2029

2017 • NDA/MAA submissions to FDA, EMA and TGA for CAM2038 for treatment of opioid dependence

2016 • New additional business strategy‒ Start building marketing & sales organization

2015 • Camurus listed on Nasdaq Stockholm stock exchange

2014 • License agreement signed with Braeburn Pharmaceuticals for CAM2038 in North America

2013 • Novartis exercises global license rights to CAM2029



Camurus’ strategyCamurus’ objective is to develop and commercialize innovative and differentiated therapeutics with the ability to advance the standard of care by improving treatment outcomes and the lives of patients with serious and chronic diseases. By combining the company’s propri-etary FluidCrystal® technologies with active pharmaceutical ingre-dients with proven efficacy and safety profiles, new and improved treatments are created. This may encompass simplified dosage reg-imens and better medication compliance and treatment outcomes, due to a more precise and steady release of the active ingredient. The use of clinically documented active ingredients enables the development of new and improved medicines at significantly lower costs and risks, compared with the development of medicines with new active ingredients. Camurus’ strategy encompasses both R&D of new product candidates, and sales and marketing of med-icines and medical devices utilizing a lean and efficient commercial infrastructure dedicated to selected niche product opportunities, indications and regional markets. In order to fully exploit the com-pany’s R&D capacity, proprietary technology, product pipeline and commercial opportunities, Camurus actively engages in strategic partnerships with leading biotech and pharmaceutical companies.

To achieve Camurus’ goals, the following strategy is pursued:

Developing R&D leadership and expertise in advanced drug delivery technologies Camurus will continue to strengthen its leadership position in advanced drug delivery. Following the recent regulatory approvals of Buvidal®, based on the company’s FluidCrystal® injection depot technology, significant resources will continue to be invested in new innovations and improvements to further advance the potential and utility of Camurus’ proprietary technologies. Examples of develop-ment areas include new customized delivery components tailored to specific pharmaceutical ingredients and product requirements, and devices developed for convenient and safe dosing that can simplify the administration of medicines for healthcare professionals and patients.

Expanding the pipeline of innovative therapies for serious and chronic diseasesThere are many chronic disease conditions for which available med-icines have significant limitations in effectiveness, safety or patient convenience. Patients living with chronic diseases often experience significant morbidity, increased mortality and a poor quality of life. Camurus is focused on research, development and commercializa-tion of new and improved therapies for serious and chronic diseases to advance the standard of care for these patients. In so doing, the company is capitalizing on its considerable development expertise and proprietary FluidCrystal® technologies, which have been vali-dated in more than 20 clinical trials and by recent product approvals. Camurus’ development focus is on commercially attractive indica-tions with significant unmet medical needs and where meaningful improvements in relation to existing alternatives may be achieved under conditions of market exclusivity.

Bringing late-stage product candidates to marketThe advancement of in-house and partnered development programs to market approval and launch is a key objective for Camurus. In November 2018, the first and only long-acting injectable medication for the treatment of opioid dependence, Buvidal® (CAM2038), was approved in the EU and Australia. Following positive topline results from a Phase 3 efficacy study of CAM2038 in chronic pain in Sep-tember 2018, the company is also preparing for planned submis-

sions of marketing authorization applications (MMA) for CAM2038 for the treatment of chronic pain in the EU, Australia and other markets. In addition to this, Camurus is preparing the registration programs for long-acting octreotide in acromegaly and neuroendocrine tumors (NET), with the planned start of the first Phase 3 trial in acromegaly in mid-2019. In some cases, Camurus has out-licensed the devel-opment and/or commercialization rights to its products and product candidates to a partner, who has the responsibility of bringing the product to the market and commercializing it in accordance with the terms of the agreement.

Building a strong commercial infrastructure Camurus has retained all development and commercialization rights for Buvidal® in Europe and other global markets, except for North America and Israel. Based on Camurus’ market assessments and long-term strategic objectives, the company is currently continuing to build its own commercial infrastructure in Europe and Australia. The commercial teams in the first wave launch countries – Finland, Sweden, UK, Germany, Denmark, Norway and Australia – are already in place, and the development of commercial teams and infrastructure in the second wave markets such as Spain, Italy and France, has begun. Camurus believes that Buvidal® for opioid dependence represents a significant opportunity to establish a cost-efficient commercial organization with focus on a limited pre-scriber base and with the potential for significant near and long-term revenue generation. In addition, the company intends to retain and/or secure commercialization rights for auxiliary product candidates in its strategic focus areas to further drive growth and future profitability.

Growing the business and expanding the commercial reach through strategic partnershipsTo further enhance its development capacity and commercial reach, Camurus enters into strategic partnerships with biotech and pharmaceutical companies with leading positions and/or a strategic focus on relevant markets and therapeutic categories. This allows the company to continue expanding its pipeline with value-gener-ating product candidates and to increase the geographic reach of its products, while maintaining a lean and cost-effective operational structure. Revenues from such partnerships typically include down payments, development and sales milestones, and royalty on prod-uct sales. In 2014, Camurus entered into a license agreement with Braeburn for the development and commercialization of CAM2038 and related product candidates for the treatment of opioid use dis-order and pain in North America. Braeburn is thereby responsible for the clinical development for approval and commercialization in the US and Camurus is entitled to milestone payments and royalty on sales. A different example is the license agreement with Rhythm from 2015, where Rhythm obtained the global development and commer-cialization rights to weekly setmelanotide for the treatment of genetic obesity disorders, based on Camurus’ FluidCrystal® technology.

Competitive strengthsCamurus’ competitive strengths contribute to the company’s positive development and its ability to realize its strategy and goal of becom-ing a profitable, science-led, commercial-stage pharmaceutical company.

The company’s competitive strengths include:

FluidCrystal® technologies The FluidCrystal® technology has been developed in-house and successfully evaluated in more than 20 clinical trials and validated by recent regulatory approvals of Buvidal® in Europe and Australia and



by the tentative approval of Brixadi™ in the US. Camurus’ business model is to develop innovative medicines by combining its propri-etary FluidCrystal® technologies with active pharmaceutical ingredi-ents that have proven efficacy and safety profiles. This approach has several benefits, such as shorter development timelines, lower costs and reduced risk of failure compared with traditional drug R&D. The FluidCrystal® technology is used with collaboration partners’ propri-etary compounds to develop new medicines under product-specific license agreements. This expands the company’s overall develop-ment capacity and is an important source of future revenues in the form of potential development and commercialization milestones and royalties on sales.

Broad and diverse pipeline including several late stage product candidates Camurus currently has about 10 programs in clinical development (Phase 1 to 3), and additional in-house and partner projects about to enter clinical development. Camurus’ lead product candidate, CAM2038, was recently given regulatory approval for the treatment of opioid dependence under the tradename Buvidal® in the EU and Australia and Brixadi™ in the US and is currently in Phase 3 development for the treatment of chronic pain. Another late-stage candidate, CAM2029, is being developed as a new treatment for acromegaly and NET, with the potential for improved efficacy and convenience for patients. CAM2043, for the treatment of pulmonary arterial hypertension (PAH) targets an orphan designation which may decrease overall development costs due to reduced requirements of patient numbers in safety and efficacy studies and potential for shorter development times – although this is balanced by the difficul-ties in recruiting patients suffering from rare diseases. The possibility for regulatory support by health authorities and extended market exclusivity up to 7 years are other potential advantages of orphan product drug development. As all products in clinical development by Camurus and its partners are based on the proprietary FluidCrys-tal® technology, significant efficiencies can be realized in preclinical development, chemistry, manufacturing and controls (CMC), and safety documentation.

Opportunity for own commercialization of Buvidal® in the EU, Australia and other selected markets Buvidal® has broad and competitive indication statements and the summary of product characteristics includes all treatment phases: initiation, stabilization, switching from daily medications and long-term maintenance treatment.

Camurus believes that Buvidal® has the potential to be a game changer in opioid dependence treatment as it may provide significant efficiencies. Current therapy with daily medication requires strict controls and rules and a high degree of supervision, which leads to increased healthcare costs and a significant burden and stigma for patients. In addition to reducing costs for administration and enhancing the quality of life for patients compared with current daily treatment options, Buvidal® has the potential to improve medication adherence and thereby contribute to reduction of relapses, over-doses and deaths.

Together with experts and third research providers, Camurus has conducted thorough market research and assessments of the commercial potential of Buvidal® in Europe and Australia, in which treatment costs, the preferences of prescribers and opinion leaders, payment structures, price and benefit aspects have been evaluated. Camurus has concluded that its own commercialization of Buvidal® in the EU and Australia represents an attractive opportunity for the company for future revenue generation, profitability and shareholder value.

Launch-ready commercial organizationRecognizing the importance of a strong commercial infrastructure and well-advanced medical affairs, market access and marketing activities at time of launch, Camurus has since 2016 invested in building its commercial organization, and experienced marketing and sales teams, complemented by effective distribution models, are now in place for launch in all first wave markets in Europe and Australia. Camurus believes that its current commercial organization with 55 people is well proportioned for the initial launch phase due to the concentrated market for opioid dependence, with most patients being treated in specialized addiction clinics in urban areas.

New and established partnerships increase development capacity and commercial reach Camurus has established several strategic partnerships to extend the reach beyond the company’s own geographical and commercial scope, and to share the costs and risks of product development. Partnerships include the collaboration with Braeburn for develop-ment and commercialization of CAM2038 for opioid dependence and chronic pain, as well as other product candidates, in North America. In addition, Camurus has several partners for sales and dis-tribution of episil® for oral mucositis pain, including Solasia for Japan and China. Furthermore, Camurus’ partner Rhythm Pharmaceuticals is developing a weekly FluidCrystal® setmelanotide formulation for the treatment of genetic obesity disorders. Camurus has also several promising early stage collaboration projects with international phar-maceutical companies in the preclinical development phase, where the combination of the partner’s proprietary drug compounds with FluidCrystal® is being evaluated.

Strong IP positionCamurus has extensive knowledge in all critical aspects of its proprietary FluidCrystal® technologies, including components, man-ufacturing aspects, application areas, packaging and stability. This knowledge will continue to grow as Camurus and its partners further develop their products, achieve more market approvals and conduct post-marketing approval activities. Camurus’ patent strategy covers all major pharmaceutical markets, including the US, EU5, Japan and China. The patent portfolio covers the FluidCrystal® technologies as well as specific products and product candidates and consist of about 330 issued patents. In addition, Camurus actively prosecutes about 135 pending patent applications worldwide and is continu-ously filing new patent applications to extend the protection of its technologies and product candidates. The duration of patents for FluidCrystal® technologies and the company’s product candidates varies geographically. Depending on aspect and claim, the patent expiry times for US FluidCrystal technology patents range from 2027 to 2033 or longer, while expected European patent expiry range from 2025 to 2033, or longer.

Buvidal® is protected by issued patents or provisional patents up to 2032, including about 30 issued patents in Australia, EU-5 and the US. The Buvidal® trademark is owned by Camurus and registered in several jurisdictions, including Australia and the EU.

Experienced management teamCamurus has a highly qualified management team with considerable industrial experience, expertise and track records across all key areas of development, commercialization and general management. The company maintains an entrepreneurial, science-led and inclu-sive corporate culture where employees are actively involved and engaged in developing new innovative therapeutic options to help patients with severe and chronic diseases to live better lives.



The average term of employment for members of the company’s management team is more than 7 years at Camurus and about 20 years in the pharmaceutical industry. Camurus’ President and CEO, and Head of R&D, Dr Fredrik Tiberg, has been with the company since 2002 and has led the development of Camurus from an early-stage research company to a rapidly-growing, publicly-listed, commercial-stage company with around 100 employees. Members of the executive team have been instrumental in the development of the FluidCrystal® technologies and the company’s innovative prod-ucts and product candidates, and thus have a deep understanding of the science involved. Over the years, members of Camurus’ management team have been involved in negotiating a significant number of major commercial agreements with international biotech and pharmaceutical companies, including with Braeburn and Rhythm.

4) Tiberg F, et al. Chapter in Long Acting Injections and Implants, Advances in Delivery Science and Technology 2012.5) Tiberg F, et al. OnDrugDelivery 2010, http|://www.|ondrugdelivery.|com/publications/Injectable%20Formulations%202010/Camurus.pdf.6) Tiberg F, et al. Drug Del. Sci. Tech., 21 (1) 101-109 2011.

Camurus’ technology platformsCamurus has developed three unique drug delivery technologies based on special combinations of lipids and their ability to spon-taneously form three-dimensional liquid crystalline nanostructures when in contact with aqueous media. These are marketed under the tradename FluidCrystal®.

FluidCrystal® injection depotTraditional long-acting injection pharmaceutical products often com-prise polymeric microparticles, where the active ingredient is encap-sulated in a biodegradable polymer matrix. Most microparticle-based products must be reconstituted in several preparation steps and injected intramuscularly with relatively thick needles. Compared with these microparticle-based systems, FluidCrystal® injection depot offers a simple and uncomplicated alternative, in terms of both man-ufacturing and administration.

6

LIQUID DRUG PRODUCTFORMULATION BEFORE INJECTION:

SPC+GDO+SOLVENT+DRUG

WATER ABSORPTION

SOLVENT RELEASE

DRUG RELEASE

LIQUID CRYSTAL (LC)

INJECTION

DEPOT BIODEGRADATION TO COMPLETE RESOLUTION

WEEKS / MONTHSHOURS SECONDS

A FluidCrystal® injection depot comprises a homogeneous lip-id-based liquid with a dissolved active pharmaceutical ingredient that can easily be injected subcutaneously using a conventional syringe with a thin needle. Upon contact with fluids in the tissue, the lipid solution transforms into a liquid crystalline gel, which effectively encapsulates the active ingredient and subsequently releases it at a controlled rate as the liquid crystalline matrix and lipid building blocks gradually degrade in the tissue.4) 5) 6) The figure below shows a typical release profile demonstrated by the peptide drug compound pasir-eotide formulated with FluidCrystal®. The release can be controlled from several days to weeks or months, depending on the choice of lipid composition and other factors. The system’s simplicity, including a spontaneous self-association to a functional structure in the body, eliminates complicated manufacturing procedures and the need for mixing (reconstitution) prior to administration.

Medicines based on the FluidCrystal® injection depot can be administered by patients themselves or by healthcare professionals without time-consuming and complicated reconstitution procedures. The long-acting release reduces the patient’s burden of administer-ing medication daily, improves the adherence to and results of the treatment, and improves the patient’s quality of life.

The following list sets out the principal characteristics of the Fluid-Crystal® injection depot system:

• Long-acting drug release

• Ease of handling and administration

• Compatible with pre-filled syringes and autoinjectors

• Small injection volume with a thin needle

• Subcutaneous dosing

• Safety profile demonstrated in clinical studies and by approved drug products

• Manufacturing by standard processes

7

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Pasireotide FluidCrystal 20 mg (SC lår, n = 12)

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Example of pharmacokinetic plasma concentration release profile for a drug compound (pasireotide) formulated with FluidCrystal® injection depot. SC – subcutaneous



Product and product candidates based on the FluidCrystal® injection depot have been studied in more than 20 completed clinical studies, from Phase 1 to registration, and are currently investigated in several ongoing clinical studies. The technology is also validated by approv-als of Buvidal® in the EU and Australia and by the Brixadi™ tentative approval in the US.

FluidCrystal® topical bioadhesiveFluidCrystal® topical bioadhesive comprises a liquid product that forms a durable bioadhesive film after administration on tissue surfaces. The film functions as an invisible patch that slowly and pre-cisely releases the active pharmaceutical ingredient systemically or locally. It also provides protection of sensitive and inflamed tissues. The formulation is suitable for prolonged local release of active ingre-dients on the skin and on mucosal membranes of, for example, the mouth, nose and throat.

Product candidates and medical devices based on the FluidCrys-tal® topical bioadhesive technology have undergone several clinical studies. This technology is also used for the medical device product episil® for the treatment of intraoral pain caused by oral mucositis, a severe side-effect of chemotherapy and radiation treatment of cancer. episil® is approved in the EU, the US, Japan, China, Australia and other countries.7)

FluidCrystal® nanoparticlesFluidCrystal® nanoparticles can resolve the issue of bioavailability for water and fat-soluble pharmaceuticals or biodegradation of sensitive drugs, such as peptides and proteins. FluidCrystal® nanoparticles are usually water based and comprise a stable emulsion of nanopar-ticles with a liquid crystalline structure. Products based on this tech-nology are administered either parenterally via injections or as a liquid sprayed onto the skin or mucous membranes.8) 9) 10)

Intellectual property strategyAll Camurus’ technologies are protected by an extensive patent portfolio with many granted patents in all major pharmaceutical mar-kets, including the US, the EU, China, Japan, Korea and Australia. Camurus’ portfolio of technology and product patents is constantly being expanded with new applications and approvals as applications are processed and new innovations are made, such as specific compositions, enhancements and new therapeutic applications. New patents can extend market exclusivities for both technologies and products and are therefore important to the company. Camurus closely monitors developments relating to its IP rights as well as competing technologies and companies. The IP strategy is mon-itored by in-house counsel and has been developed in close and long-standing collaborations with Camurus’ external international patent attorneys and advisors.

7) Barauskas J, et al. Mol. Pharmaceutics 2014, 11, 895−903.8) Barauskas J, et al. Nano Lett., Vol. 5, No. 8, 2005, 1615-1619.9) Barauskas J, et al. Langmuir 2005, 21, 2569-2577.10) Tiberg F, et al. Drug Del. Sci. Tech., 21 (1) 101-109 2011.

pharmaceutical productsBuvidal® (CAM2038) – the first weekly and monthly buprenorphine injection for individualized treatment of opioid dependence

SummaryTo address the significant need of new and more effective treatments of opioid dependence that can improve treatment outcomes and quality of life for patients with opioid dependence, Camurus has developed Buvidal® (CAM2038), weekly and monthly buprenorphine depots, as the first long-acting medicine approved for treatment of treatment of opioid dependence in the EU and Australia, and tenta-tively approved in the US under the name Brixadi™

Buvidal® prolonged release solution for injection has been devel-oped for the treatment of opioid dependence within a framework of medical, social and psychological treatment. Buvidal® is designed for flexible dosing and is available in four weekly strengths (8, 16, 24 and 32 mg) and three monthly strengths (64, 96, and 128 mg), enabling treatment to be tailored to the patient’s individual needs, and allow-ing for direct dose-adjusted transition from daily therapy. Buvidal® is administered by healthcare professionals to enhance treatment adherence, while potentially minimizing the risks of diversion, misuse, overdose and accidental exposure to children and teenagers.

Buvidal® can relieve patients from the daily reminder and burden of the disease and allows the healthcare provider to focus on treating the disease and counseling the patient rather than policing medical compliance. In a Phase 3 long-term safety study, Buvidal® received high ratings of patient satisfaction with 83 percent of patients responding that Buvidal® treatment was better than their previous sublingual treatment (15 percent slightly better and 68 percent much better).

9

Much worse

Slightly worse

About the same

Slightly better

Much better

83% POSITIVE

N=133

Response to the question “How was your experience with CAM2038 (Buvidal®) compared to your previously prescribed sublingual buprenorphine treatment?” from patients included in the long-term Phase 3 safety trial.

In anticipation of the market approvals of Buvidal® in the EU and Australia, Camurus has built up a commercial organization in these regions, which is fully operational and has launched Buvidal® in the first wave markets in Finland, Sweden, the UK and Germany. US commercialization of the products under the tentative tradename



Brixadi™ is the responsibility of Camurus’ license partner Braeburn, whereas Camurus is entitled to royalty and milestones on net prod-uct sales.

Based on the high unmet medical need and the important product and clinical attributes of Buvidal®, the market opportunity for Buvidal® and Brixadi™ is estimated to be significant. The inde-pendent analysis company GlobalData recently predicted US sales of Brixadi™ to around 1.2 billion USD in 2027.11) In Europe and Australia, Camurus estimates the market opportunity for long-acting buprenorphine injectable to 200-300 million Euros annually.12)

In the US, a final market approval of Brixadi™ is required before the products can be marketed and sold. For the monthly depot, this is subject to the expiration of an exclusivity period of another product on the market, Sublocade™, which may not last longer than Novem-ber 2020 or earlier if successfully appealed. The exclusivity period only affects the monthly Brixadi™ product and the weekly product could therefore be resubmitted, approved and launched separately prior to the expiry of the exclusivity period.

Opioid dependenceOpioid dependence is a serious, chronic and relapsing disease that can cause major health, social and economic problems. Symptoms of opioid dependence include a strong compulsive desire to use opi-oids, increased tolerance to the dose taken, failure to perform daily tasks and maintain relationships and difficulty reducing use. With-drawal symptoms include nausea, muscle aches, diarrhea, sleeping

11) Opioid Use Disorder (OUD): Opportunity Analysis and Forecasts to 2027, GlobalData 2018.12) Company estimation, see below.13) Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence, WHO, 2009, https|://www.|who.|int/substance_abuse/publications/opioid_dependence_

guidelines.pdf.14) World Drug Report 2018.15) U.S. Opioid Prescribing Rate Maps, CDC Centers for Disease Control and Prevention, https|://www.|cdc.|gov/drugoverdose/maps/rxrate-maps.html.16) Heroin Overdose Data, CDC Centers for Disease Control and Prevention, https|://www.|cdc.|gov/drugoverdose/data/heroin.html.17) SAMHSA, Results from the 2017 National Survey on Drug Use and Health, Sep. 2018.18) CDC https|://www.|cdc.|gov/media/releases/2018/s1129-US-life-expectancy.html.19) The Council of Economic Advisers, November 2017.20) Center for Disease Control & Prevention 2018.21) European Drug Report 2018, EMCDDA, http|://www.|emcdda.|europa.|eu/edr2018_en.22) Statistical Bulletin 2018 — overdose deaths, EMCDDA, http|://www.|emcdda.|europa.|eu/data/stats2018/drd_en.

trouble, a low mood and cravings. Health and social consequences of opioid dependence include overdose, suicide, transmission of HIV and hepatitis B and C through infected needles, unemployment, criminal activity and incarceration.13)

Dependence on prescription and illicit opioid drugs, including heroin, is a growing global public health challenge. According to the World Drug Report, approximately 34 million individuals globally use opioids for non-medical purposes and an estimated 127,000 people die each year from opioid overdoses.14) Opioids top the list of drugs that cause the greatest burden of disease and drug-related deaths worldwide. In the US, opioid addiction has reached epidemic proportions, threatening not only public health but economic output and national security. The opioid epidemic predominantly stems from the overuse of opioid medications, prescribed primarily for the treatment of pain. In 2017, US healthcare providers wrote more than 190 million prescriptions for opioids.15) Misuse of prescription painkillers often lead patients to turn to heroin since it is a cheaper alternative to prescription drugs, accounting for four out of five new heroin users.16) In 2017, there were approximately 2.1 million people diagnosed with opioid use disorder and close to 50,000 dying from opioid overdoses in the US.17) This is now the most common cause of death in people in the US under 50 years of age, and a main cause for the decline of US life expectancy seen over the past few years.18) In a White House report from November 2017, it was estimated that the US opioid crises annually causes a USD 504 billion economic burden to society.19)

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Number of fatal opioid overdoses in the US.20)

In Europe, an estimated 1.3 million people engage in high-risk opioid use, with only about 630,000 receiving medical treatment.21) Each

year, about 9,000 Europeans die from drug-related overdoses, of which the majority is due to opioids.22)



Current treatments and their limitations Medication-assisted treatment of opioid dependence includes the use of medications in combination with counselling and behavioral therapies.

Of around 1.3 million high-risk opioid users in Europe, less than half (630,000) receive opioid dependence treatment (see figure

23) European Drug Report 2018, EMCDDA, http|://www.|emcdda.|europa.|eu/edr2018_en.24) Dale-Perera A et al. Heroin Addict Relat Clin Probl. 2012;14(4):23-38.25) National opioid pharmacotherapy statistics (NOPSAD) 2017. https|://www.|aihw.|gov.|au/reports/alcohol-other-drug-treatment-services/nopsad-2017/contents/summary.26) Benyamina A, Stöver H. Heroin Addict Rel Clin Probl. 2012;14(4):65-80.27) Khanna IK, Pillarisetti S. J Pain Res. 2015;8:859–70.28) Schuckit MA. N Engl J Med. 2016;375(4):357-68.29) Coe MA, et al. J Addict Med. 2018; Oct 23. Epub ahead of print.30) Public Health England. https|://www.|gov.|uk/government/publications/alcohol-and-drug-prevention-treatment-and-recovery-why-invest/

alcohol-and-drug-prevention-treatment-and-recovery-why-invest.31) EMCDDA Drug Report 2018. 32) WHO Drug Report 2018. 33) Connery HS. Harv Rev Psychiatry. 2015;23(2):63-75.

below).23) Of these, approximately 38% receive buprenorphine or buprenorphine/naloxone, while methadone accounts for approx-imately 60%. The estimated average treatment time for European patients was 3.7 years in 2012.24) In Australia there are an estimated 49,000 patients in treatment for opioid dependence, of which approximately 35% receive buprenorphine.25)

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Germany UK Italy Spain France Australia

Number of high-risk opioid users in Europe and Australia by major countries. There are about 1.3 million high-risk opioid users in Europe and about 150,000 in Australia, of which less than 50% are in treatment.23)

There are several reasons why more than half of the patients with opioid dependence are not in treatment, including poor access to treatment and the burden of stringent treatment rules and regula-tions. Patients have described how better access to treatment and less burdensome treatment rules would have encouraged them to start treatment earlier.26)

Buprenorphine treatment benefits The potency of buprenorphine is at least 30 times higher than that of morphine, but unlike morphine and methadone, buprenorphine is a partial mu-opioid receptor agonist, which means that it does not have the full opioid effects.27) Buprenorphine has therefore much less risk of causing respiratory depression and overdose, even at high buprenorphine doses. Buprenorphine produces milder euphoric and sedative effects compared with morphine and methadone while still occupying opioid receptors. Moreover, buprenorphine has a higher

affinity for the mu-opioid receptor than other opioids and can there-fore block the effects of other opioids, such as heroin.28), 29)

Opioid dependence treatment with buprenorphine is associated with substantial benefits for patients and society, such as reductions in illicit opioid use, criminal activity, fatalities due to overdoses and the transmission of infectious diseases, such as HIV.30), 31), 32) Buprenor-phine treatment also reduces hospital admissions, emergency room visits, morbidity and mortality, and improves quality of life for the individual. Buprenorphine treatment also reduces hospital admis-sions, emergency room visits, morbidity and mortality, and improves quality of life for the individual. Additionally, buprenorphine treatment is associated with a lower risk of overdose and diversion compared with methadone treatment, and thus offers improved safety and flexi-bility to both patients and physicians.33)

Buprenorphine treatment for opioid dependence typically con-sists of three phases:

Induction The first days of treatment during which the patient is transitioned from illicit opioid use to treatment with the partial agonist buprenorphine. The goal of the induction phase is to rapidly suppress withdrawal and cravings to enable long-term treatment and recovery. It is important to start with a high enough dose of buprenorphine during the induction phase.

Stabilization The initial weeks of treatment, during which the patient is frequently monitored at clinic visits. The dose may be adjusted to obtain a dose that is tolerable and that effectively reduces opioid withdrawals and cravings and blocks the effects of illicitly used opioids.

Maintenance treatment

The longest period that a patient is on buprenorphine is the maintenance phase, which can be chronic. During the maintenance phase, the dose may be slowly decreased, and treatment may be shifted to long-term recovery.



Daily treatment limitationsAlthough sublingual buprenorphine or buprenorphine/naloxone or oral methadone treatments are demonstrated to be effective, they

34) Connock M, et al. Health Technol Assess. 2007;11(9):1-171, iii-iv.35) Fischer G, et al. Heroin Addict Relat Clin Probl. 2012;14(4):39-50.36) Benyamina A, Stöver H. Heroin Addict Relat Clin Probl. 2012;14(4):65-80.37) Skinner HG, et al. Trends in Emergency Department Visits, 2006–2011, Statistical Brief #179, Published 2004.38) Indivior Morgan Stanley Global Healthcare Presentation, September 2018.39) Vivitrol® Prescribing Information.

have significant limitations, which may vary depending on region and treatment system.

Limitations of current daily opioid dependence therapy:34),35),36),37)

Low retention in treatment Almost half of the patients who initiate opioid dependence treatment with daily buprenorphine medications discontinue treatment within three to six months.

Continued use of illicit opioids A majority, about 60 percent, of patients with opioid dependence report some continued use of illicit drugs on top of their prescribed medication.

Medication diversion and misuse About one third of all prescribed daily buprenorphine medication are diverted. This can result in suboptimal treatment outcomes and subtherapeutic dosing by patients and fear of diversion and misuse amongst prescribers.

Burdens of daily treatment are a barrier

Stringent and burdensome treatment rules, including supervised dosing, constitute significant barriers for treatment. They can also be stigmatizing for patients and costly for healthcare provid-ers and society.

Escalating number of emergency department visits

The increasing prescription of buprenorphine-containing tablets and films has resulted in a large increase in the number of emergency department visits in the US.

Pediatric exposure For patients who receive take home daily buprenorphine medication and have children, there is a significant risk of life-threatening accidental pediatric exposure. About 1500 emergency depart-ment visits involved ingestion of buprenorphine by children under 6 years in the US 2010-11.

Injectable long-acting treatments of opioid dependenceBuvidal® is the only long-acting treatment for opioid dependence approved in the EU and Australia, and the only weekly and monthly buprenorphine depot that can be individually dosed according to patients’ needs.

Sublocade™ is a monthly buprenorphine injection depot that was approved in the US in November 2017 and launched by Indivior in March 2018. The indication of use is treatment of opioid use dis-order in patients who have initiated treatment with a transmucosal buprenorphine‐containing product followed by dose adjustment for a minimum of 7 days, i.e. not including treatment initiation. Treatment with Sublocade™ starts with two monthly 300 mg doses given as 1.5 mL injections, which is more than three times the volume of the largest monthly Buvidal® dose volume. After two months, patients are recommended to continue treatment with 100 mg monthly Sub-locade™ dose. The pivotal Phase 3 study for Sublocade™ was a randomized placebo-controlled study in patients with opioid depen-dence who before randomization were pretreated with sublingual buprenorphine/naloxone film for up to 14 days and who had shown

only had mild withdrawal and craving symptoms. Sublocade™ has not been studied in a comparative Phase 3 study versus active control. The product requires cold-chain distribution and refriger-ated storage, which is further complicated by Sublocade™ being a controlled drug. The initial interest from physicians and patients has according to Indivior been good, but the conversion of prescription to actual injections has been disappointing, partly due to extended delivery timelines of initially up to two months.38)

Vivitrol® is available in the US since its approval in 2010 and is marketed by Alkermes. It is based on the opioid antagonist naltrex-one encapsulated in polymeric microparticles. Vivitrol® is injected as a 3.4 mL intramuscular injection once monthly using a 40 or 50 mm long, 20-gauge needle. The product must be stored refrigerated and needs to be conditioned for at least 45 minutes prior to injection. Treatment is complicated by the fact that patients must go through a detox and be abstinent during 7 to 10 days before starting treatment with Vivitrol®.39) which is difficult and may expose then patients to risks of relapse and overdosing. The use of Vivitrol® outside the crim-inal justice system has been limited, but 2017 sales were still USD 269 million.

13

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Approved 2010

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Camurus/Braeburn

Indivior

Alkermes

PRECLINICAL PHASE I PHASE II PHASE III REGISTRATION APPROVAL

US

US

Vivitrol® 2017 sales $269M2 US

Europe

Europe

Australia

Australia Est. Q3 2019

Buvidal Weekly & Monthly

Sublocade™ Monthly

Tentative approval Dec 2018

Approved Nov 2018



Buvidal® has the potential to overcome the burdens and risks associated with daily medication-assisted treatment and improve outcomes from the first day of treatment. Buvidal® is developed to suit all patient needs from initiation of opioid dependence treatment

40) Albayaty M, et al, Adv Ther. 2017 34(2):560-575.

up to and including the maintenance phase of treatment. Overall, Camurus believe that Buvidal® has several advantages over existing daily products as well as long-acting products (long-acting products are only available in the US), see table below.

ProductWeekly dosing

Monthly dosing

Multiple doses

Choice of inj. site

Small needle

Low injection volume

Room temp. storage

Clinical data vs. Active control

Buvidal® ➙ ➙ ➙ ➙ ➙23G

➙0.16-0.64 mL

➙ ➙

Sublocade™ – ➙ – – 19G 0.5-1.5 mL – –

Vivitrol® – ➙ – – 20G 3.4 mL – –

Buvidal® is approved in the EU and Australia, Sublocade™ is approved in the US and Canada, and Vivitrol® is approved in the US.

Clinical results The safety and efficacy profiles of Buvidal® have been evaluated in a comprehensive clinical program comprising seven clinical studies in a total of 944 patients and healthy volunteers, including several pharmacokinetic studies, a pivotal Phase 2 opioid challenge study, a pivotal Phase 3 efficacy study against standard treatment with sublingual buprenorphine/naloxone, and an open-label Phase 3 long-term safety study including both new-to-treatment patients as well as patients switched from sublingual buprenorphine. Based on the results from these studies, registration applications for Buvidal®/ Brixadi™ were submitted via the hybrid and 505(b)(2) regulatory pathways in the EU and US, respectively. These pathways allow referencing to be made to the efficacy and safety data for existing reference products.

Pharmacokinetics suited for weekly and monthly dosing Buvidal® provides a rapid establishment of therapeutic buprenor-phine plasma concentrations, which peak during the first 24 hours and then slowly decay over either one or four weeks. The figure below illustrates population pharmacokinetic profiles for weekly and monthly Buvidal® compared to daily sublingual buprenorphine.40)

Buvidal® is provided in a convenient, ready-to-use pre-filled syringe.

Camurus does not know of any other long-acting injectable treat-ments in active clinical development in the EU or the US.

Buvidal® – weekly and monthly buprenorphine for individualized treatment of opioid dependenceBuvidal® was approved in the EU in November 2018 for treatment of opioid dependence within a framework of medical, social and psychological treatment. In the same period, Buvidal® Weekly and Buvidal® Monthly were approved for maintenance treatment of opioid dependence in Australia. Buvidal® is designed for flexible dosing and is available in four strengths (8, 16, 24 and 32 mg) for weekly administration and three strengths (64, 96, and 128 mg) for monthly administration, enabling treatment to be tailored to the patient’s individual needs. Buvidal® is administered by healthcare professionals to enhance treatment adherence and mitigate risks of

diversion, misuse, overdose and accidental exposure to children and teenagers.

Formulated with Camurus’ FluidCrystal® injection depot tech-nology (see above), Buvidal® is presented ready for use in pre-filled syringes for weekly or monthly administration as small dose volume (0.16–0.64 mL depending on dose) subcutaneous injection through a thin, 23-gauge needle. Following injection, the fluid spontaneously transforms into a liquid crystalline gel that releases buprenorphine at a steady rate during the period in which the depot slowly degrades in the subcutaneous tissue. The product is equipped with a needle safety device that automatically covers the needle following injec-tion. Buvidal® has been developed for room temperature storage, avoiding the need for cold chain distribution and refrigerator storage. Therefore, no mixing steps or room temperature conditioning are required prior to administration.



Since both weekly and monthly Buvidal® give dose-proportional buprenorphine levels, dose adjustments are easily made to match sublingual doses and patients’ clinical needs.

Noninferiority and superiority versus daily sublingual buprenorphine/naloxoneBuvidal® was studied in a pivotal Phase 3 clinical trial evaluating its safety and efficacy among 428 adult patients with opioid depen-dence and using sublingual buprenorphine as an active comparator. In the study, Buvidal® was first shown to be at least as effective as standard treatment with daily buprenorphine/naloxone for the pri-mary endpoint of the mean percent urine tests negative for illicit opi-oids (p<0.001). Superior treatment effect was then demonstrated for the key secondary endpoint of cumulative distribution function (CDF) for the percent urine tests negative for illicit opioid use (p=0.008).41) The corresponding FDA endpoint included self-reported and results were similar (p=0,004).

The below figure shows the cumulative distribution of the per-centage of study participants with opioid-free urine weeks in the two treatment groups over the 24-week treatment period.

41) Lofwall et al. JAMA Int. Med. 2018;178(6); 764-773;42) Studie HS-14-499, data on file.43) Haasen, C, et al, J Subst Abuse Treat. 2017;78:22-29.44) Lofwall MR, et al, JAMA Inter Med. 2018; 178(6)764–773.45) Walsh et al, JAMA Psychiatry 2017;74(9):894-902.

High treatment retention42)

Retention in treatment was high, with 156 of 227 patients (68.7%) completing the 48-week treatment period in the long-term safety study, see figure below.

18

0%

20%

40%

60%

80%

100%

0 4 8 12 16 20 24 28 32 36 40 44 48

Ret

entio

n in

trea

tmen

t(%

)

Treatment Week

0%

20%

40%

60%

80%

100%

0 4 8 12 16 20 24 28 32 36 40 44 48Ande

l pat

ient

er k

var i

beh

andl

ing

(%)

Behandlingsvecka

Retention in treatment in the long-term Phase 3 safety trial.

Effective suppression of withdrawal and cravingsEffective suppression of withdrawal and cravings is a primary aim of opioid agonist treatment. In the Phase 3, long-term safety study, Buvidal® demonstrated an impressive long-term suppression and control of withdrawal and cravings in both new-to-treatment patients and patients switched from daily sublingual buprenorphine across the 48-week treatment period. These result have also been con-firmed in other clinical trials with Buvidal®.43),44),45)

Population PK analysis and modelling based on data four clinical studies (N=236). Diagnostic testing demonstrated predictive BPN concentrations and good agreement between observed and predicted data percentiles. SL BPN, sublingual buprenorphine

Median Buvidal® weekly 32mg95% CI Buvidal® weekly 32mgMedian SL buprenorphine 24mg95% CI SL buprenorphine 24mg

Pla

sma

bupr

enor

phin

eco

nc(n

g/m

L)

Time (Days)

Pla

sma

bupr

enor

phin

eco

nc(n

g/m

L)

Time (Days)

Median Buvidal® monthly 128mg95% CI Buvidal® monthly 128mgMedian Buvidal® weekly 32mg95% CI Buvidal® weekly 32mg

Population pharmacokinetic analysis and modelling based on data from four clinical Phase 1 and Phase 2 trials (N=236). SL: sublingual.

17

Parti

cipa

nts

(%)

% opioid-negative urine samples: week 4-24

0102030405060708090

100

0 10 20 30 40 50 60 70 80 90 100

CAM2038

SL BPN/NX

Buvidal® (n=213)

Sublingual buprenorphine/naloxone (n=215)

Stud

iede

ltaga

re(%

)

% opioidnegativa urinprov: vecka 4-24

0102030405060708090

100

0 10 20 30 40 50 60 70 80 90 100

CAM2038

SL BPN/NX

Buvidal® (n=213)

Sublingualt buprenorfin/naloxone (n=215)

Cumulative percentage of patients versus the mean opioid-free urine samples for treatment weeks 4 to 24.



Blockade of opioid effects from the first dose Another important objective of medication-assisted treatment of opioid dependence is to reduce or eliminate the use of illicit opioids. The ability of Buvidal® to block the positive effects of illicit opioids in patients with opioid dependence was studied in a Phase 2 study in non-treatment-seeking participants with moderate-to-severe opioid dependence. Buvidal® met the primary endpoint, demonstrating complete blockade of drug-liking after intramuscular hydromorphone injections from the first Buvidal® dose. Furthermore, tolerability was good across the course of treatment.46)

Safety profile comparable to daily sublingual buprenorphine/naloxoneThe safety of Buvidal®, including local tolerance at the site of injec-tion, was studied in all clinical trials. The results unanimously showed a good safety profile, which was comparable to the safety profile of sublingual buprenorphine, and good local tolerability at the site

46) Walsh S, et al. JAMA Psychiatry. 2017;74(9):894-902.47) Studie HS-14-499, data on file.

of injection. The most commonly reported adverse events in the Phase 3 trials were injection site reactions such as pain, swelling and erythema, headache and nausea. The injection site reactions were in most cases transient and in all cases, but one event of transient pain, of mild or moderate intensity.47)

Market potential and the global commercialization of Buvidal®

In accordance with its global commercialization strategy, Camurus initiated the launch of Buvidal® on the European markets soon after approval and is preparing for a second quarter launch in Australia. Commercialization rights for North America have been out-licensed to Braeburn, who also has an option to commercialize Buvidal® in China, Japan, Taiwan and South Korea.

Withdrawal symptoms (left figure, assessed using the Clinical Opiate Withdrawal Scale (COWS), scores 0 to 48) and craving scores (right figure, assessed using a visual analogue scale, scores 0 to 100) over time in the long-term Phase 3 safety trial. 20

CO

WS

(Tot

al s

core

)

Treatment day

0

2

4

6

8

10

12

0 50 100 150 200 250 300 350

Transferred from SL BPN (n=190)

New to treatment (n=37)

0

10

20

30

40

50

60

70

80

90

100

0 50 100 150 200 250 300 350

Transferred from SL BPN (n=190)

New to treatment (n=37)

Treatment day

Nee

d to

use

VAS

(mm

)

22

Braeburn Braeburn option rightCamurus entry markets Medison (Israel)Camurus



Camurus is also assessing the market opportunity in countries outside Europe, Australia and Braeburn’s and, depending on the opportunity, Camurus will invest in own sales or find a suitable license or distribution partner. Camurus has already signed a license agreement with Medison, a leading Israeli pharmaceutical company, for the promotion and distribution of Buvidal® in Israel.

Market potential in Europe and Australia Camurus believes that Buvidal® has the potential to transform the opioid dependence markets. With the broad and competitive labels obtained for Buvidal® in the EU and Australia, the Company believes there is potential to reach a wide group of patients, including patients currently treated with sublingual buprenorphine products, low dose methadone and those entering a new treatment episode. Additionally, as Buvidal® addresses one of the key reasons why many

48) Benyamina A, Stöver H. Heroin Addict Relat Clin Probl. 2012;14(4):65-80.49) a) EMCDDA 2018 Drug report; b) Camurus estimate; c) Benyamina A, Stöver H. Heroin Addict Relat Clin Probl. 2012;14(4): 65-80; d) Camurus data on file 2018 Patient qualitative study.50) Market Access Dynamics in Opioid Addiction: Probing Prescriber Preferences and Payer Strategies for Current and Emerging Agents in the EU5, Decision Resources, 2015.51) Camurus estimat, jämför retention i Buvidal® långtidssäkerhetsstudie av ~270 dagar.52) Camurus data Simon Kucher and Partners pricing research 2018.

individuals do not seek treatment (for example, the 30 percent that reportedly do not enter treatment due to the rules and regulations), there is a significant opportunity to also attract patients currently out of the treatment.48)

In many European countries, daily opioid dependence therapy requires closely monitored dispensing and intake of medication, which intrudes on patients’ lives and is costly for healthcare systems. Since Buvidal® only requires weekly or monthly doses, the conditions are in place for cost savings for healthcare systems and an increased quality of life for patients. Variations of treatment practices between countries, for example with differing intervals for psychosocial con-sultation, makes Buvidal®, with its flexible dose and dosing intervals, an attractive treatment alternative in in the EU and Australia as well as on other global markets.

Patients on buprenorfina)

Patients on low doseb)

Patients entering a new treatment

espisodea)

Users out of treat-ment due to rules and burdena), c), d)

Total addressable

market

Estimated number of patients suitable for buprenorphine long-acting injectable (LAI) treatments in EU and Australia.49)

The estimated total number of patients suitable for treatment with long-acting buprenorphine products is 740,000 in the EU and Australia. Based on a modest patient fraction of 20-30 percent (see physician estimates below)50) this corresponds to annual sales of approximately 200-300 million Euros for long-acting injectables (LAIs) in the EU and Australia. The estimate also assumes a con-servative yearly average treatment length of 180 days51) and a price point comparable to current long-acting antipsychotics.52)

24

740,000 möjliga

patienter i EU och

Australien

20 – 30% marknadsandel för injektions-

depå

Tid i behandling 180 dagar i

medeltal

Pris jämförbart

med psykofarmaka

depå

Uppskattad marknadspotential200 – 300 m€

för LAIs

740,000 patients in

addressable market in EU and Australia

20 – 30% on depot

medication

Average length of treatment ~180 days

Price point comparable

to depot antipsychotic medications

Estimated market size

€200 - €300m for LAIs at peak

23



Market potential in the USBrixadi™ (the US tradename of Buvidal®) represents a significant opportunity in the US with a fundamentally differentiated product offering weekly and monthly flexible dosing that matches current clinical practice and allows induction without the need for oral titra-tion and initiation. Note that about 40 percent of the prescriptions in the US are for one week or shorter, while 28 percent are monthly prescriptions. Another important reason for the positive view on Buvidal® is the possibility to initiate treatment of naïve patients with Buvidal® from the first day of treatment.

Policymakers in the US are strongly advocating for medica-tion-assisted treatment (MAT). FDA Commissioner Scott Gottlieb indicated that there are no more easy solutions to the opioid crisis and that increased access to medication assisted treatment is a cor-nerstone in FDA’s response to the crisi.53) Payers in the US are faced with an extreme economic burden of opioid use disorder, estimated to cost the US economy in the region of half a trillion USD in 2015.54)

An estimated 11.8 million individuals misuse opioids in the US, of which 2.1 million reach the criteria for diagnosis of opioid use disorder.55) Only about half of these, 1.1 million, currently receive medication-assisted treatment with about 780,000 being treated with buprenorphine.56)

Recent research by GlobalData predicts the US opioid depen-dence market to grow by a 10% CAGR during the next 10-year period and to reach USD 4.3 billion in 2027.57) This is primarily driven by depot formulations gaining market share. According to the same report, Brixadi™ is expected to take a patient share of 11% in 2027, corresponding to USD 1.2 billion in sales.

53) Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis, Aug 29, 2018 https|://www.|fda.|gov/NewsEvents/Newsroom/PressAnnouncements/ucm618831.htm.

54) The Council of Economic Advisors, November 2017. The Underestimated Cost of the Opioid Crisis. Accessed on January 18, 2018.55) SAMHSA, Results from the 2016 National Survey on Drug Use and Health, Sep. 2017.56) Derived from Symphony Health Solution Patient Tracker, 2016. Symphony Health Solutions, Integrated Audit, 2017.57) Opioid Use Disorder (OUD): Opportunity Analysis and Forecasts to 2027, GlobalData 2018.58) Market Access Dynamics in Opioid Addiction: Probing Prescriber Preferences and Payer Strategies for Current and Emerging Agents in the EU5, Decision Resources, 2015.59) Camurus Data 2018 Simon Kucher and Partners pricing research 2018.

25

2017 2027

Long-acting injectables

Daily medication

US$ 1.8 billion

US$ 4.3 billion

$1.3 billion$3.1 billion

$1.2 billion$264 m

2017 2027

Långtidsverkande injektioner

Daglig medicinering

1,8 miljarder USD

4,3 miljarder USD

1,3 miljarderUSD

3,1 miljarder USD

1,2miljarderUSD$264 m

Perceptions of Buvidal® from patients and healthcare providersPhysician surveys demonstrate a clear recognition of Buvidal® and the benefits the product may bring to patients and healthcare provid-ers. Based on EU physician estimate, weekly and monthly buprenor-phine depot shares ranged between 22-43 percent.58), 59)

Both qualitative and quantitative research projects have been performed to gain an in-depth understanding of patients’ percep-tions of depot formulations. Patients clearly understand the value Buvidal® could bring to their treatment and recognize the reduction in the burden and stigma of treatment, the benefit of having consistent therapeutic exposure and that reducing dosing frequency will make life easier. More than 50% of patients in the survey responded that they definitely or probably will try Buvidal® when it is available. The results align well with the patient satisfaction scores in the long-term Phase 3 study, where 83% of patients reported that Buvidal® was slightly or much better than their previous treatment with sublingual buprenorphine.

A majority of surveyed medical specialists responded that they would be willing to prescribe Buvidal® to their patients with opioid dependence. They also estimated the share of patients that would be prescribed Buvidal® monthly (q4w) or Buvidal® weekly (q1w).

96%

n=52

27

HCPs’ willingness to prescribe CAM2038 Anticipated share of patients on CAM2038 q4w if available Anticipated share of patients on CAM2038 q1w if available

96%

n=50

39%q4w

22%q1w

94%

n=50

36%q4w

25%q1w

86%

n=50

43%q4w

27%q1w

France169,700 patients

86%

n=51

31%q4w

30%q1w

Germany78,800 patients

UK138,400 patients

Italy62,800 patients

Spain59,200 patients

37%q4w

22%q1w



European and Australian commercialization of Buvidal® Patients living with opioid dependence mainly live in urban areas and are treated in specialized clinics. Due to the concentration of clinics and patients, it is Camurus’ assessment that the market can be addressed with a relatively small sales force in the EU, Australia and other markets where treatment systems exist. The company has therefore organized its commercial organization as a ‘hub & spoke’ model with centralized key functions and scalable resources for market access and sales in countries and regional markets. At launch regional offices are established in Cambridge, UK, for Norther Europe including the Nordics, in Mannheim, Germany, for Central Europe, in Paris, France, for Southern Europe, and in Sydney, Aus-tralia. To date, the commercial organization total headcount is 55 people, of which 83% are customer facing sales, marketing, medical affairs and market access experts. It will be expanded following pric-ing and reimbursement approvals and growing patient numbers in the respective countries, and by 2020-2021 the team could consist of about 100 people across the EU and Australia.

In January 2019, Camurus initiated the European commercial-ization of Buvidal® with initial launces in Finland and Sweden, which were followed by UK, Germany and Denmark. Patients were initiated on treatment just days after the product was shipped and distributed to pharmacies. The initial response from patients and physicians has been encouraging. Buvidal® has already been launched in all first wave EU markets, and Norway and Australia will follow in the

second quarter of 2019. The overall launch sequence for Buvidal® is determined by reimbursement time and the market potential of each market, see table below.

WAVE 1 WAVE 2 WAVE 3 WAVE 4

FinlandSweden

UKGermanyDenmarkNorway Australia

ItalySpain

FranceIsrael

BeneluxPortugalGreeceCroatiaIrelandCzechAustriaPoland

Rest of the world

310,000 patients:45% of totalEU/Australia

+299,000 patients:89% of totalEU/Australia

+86,000 patients:98% of totalEU/Australia

Buvidal® launch sequence in EU and Australia.

Camurus estimates that 45% of all patients in Europe and Australia will have access to Buvidal® at the end of the second quarter of 2019. The reimbursement process in the second wave markets typi-cally takes 9–12 months after regulatory approval, and thus launches in these countries are expected in the fourth quarter of 2019 and first quarter 2020.

To secure an efficient product supply from manufacturing to the clinics and patients, Camurus has established the distribution network for Buvidal® in readiness for launch in each country, see figure below.

28

Import-/expor-

licenser

Leveranstill grossist

Leverenstill klinikTillverkning

Leverenstill sjukhus

eller apotek

Doseringpå klinik

4 veckor 3–5 veckor ~24 timmar

Import/export

licences

Delivery to wholesaler

Delivery to

Clinic/HCP

Manufacture

Delivery to hospital

or retail pharmacy

Administration at clinic

4 weeks 3–5 weeks ~24 hours

Schematic Buvidal® distribution chain in the EU.

Aside from preparing for launch, Camurus is currently performing a Phase 4 post-marketing clinical study comparing Buvidal® weekly and monthly with standard of care in Australia. The study focuses on patient satisfaction, quality of life and health economic factors. In addition, the Government of New South Wales in Australia is spon-soring a clinical study investigating the use of Buvidal® for treatment of opioid dependence in the prison setting.

Pricing and reimbursementThe EU is a diversified market where the medical agencies of the respective member states have different guidelines and criteria for pricing and reimbursement levels. In the EU there is a push towards lower prices of pharmaceuticals and to obtain reimbursement, most countries require pharmaceutical companies to demonstrate the cost advantages of their products compared to currently available therapies. Buvidal®, with its many positive attributes and demon-strated ability to improve clinical outcomes, can create a significant health economical value for the society. Camurus believes that this will secure adequate prices and reimbursement levels for Buvidal® in line with current long-acting antipsychotics. The price at pharmacy for Buvidal® in the first wave markets is at launch in the range of 9–14 Euro per day, in line with pricing of long-acting anti-psychotics. All

weekly and monthly doses have been priced at the same level per treatment day so that the price will not interfere with clinical judge-ment and patients’ needs.

Partnership with Braeburn In November 2014, Camurus entered into an exclusive licensing agreement for CAM2038 (Brixadi™, the US trade name for Buvidal®) with Braeburn. Braeburn thereby obtained exclusive rights to Brixadi™ for the treatment of opioid dependence and pain in North America, with option rights in Japan, Korea, Taiwan and China. Cam-urus retained all rights in Europe and the rest of the world, including Australia.

Braeburn is a US pharmaceutical company dedicated to delivering solutions for people living with the serious, often fatal, consequences of opioid dependence. Braeburn is privately owned, initially backed by Apple Tree Partners, a US-based venture capital firm dedicated to the development of companies in the healthcare sector. In a USD 110 million mezzanine financing round announced in January 2018, the investor base was expanded to include Avista Capital Partners, Deerfield Management, New Leaf Venture Partners, RA Capital Management and Rock Springs Capital.



Braeburn’s management team has decades of experience of successfully launching and growing commercially successful phar-maceutical products. Collectively, the management has experience of more than 50 specialty pharma product launches in the US. The company also has extensive experience of clinical and regulatory development in areas including addiction and psychiatric disorders.

Under the licensing agreement, Camurus received an up-front license fee of USD 20 million (SEK 148.4 million)60) from Braeburn. Since 2014, Camurus has received another USD 4 million (SEK 35.2 million)60) for the start and completion of the CAM2038 Phase 3 pain efficacy trial as well as USD 1.5 million (SEK 13.8 million)60) for the buprenorphine combination product Phase 1 trial for the treatment of pain. In addition, Camurus is eligible for a further USD 35 million in development milestones linked to the final approval of Brixadi™ for opioid dependence in the US, USD 17 million for the development and approval of the pain indication for Brixadi™ in the US, and USD 7 million for the development and approval of a buprenorphine com-bination product in a pain indication in the US. Camurus is also enti-tled to receive up to an additional USD 75 million in sales milestones, and a mid-teen percentage of royalties on annual product net sales.

Brixadi™ monthly depot blocked by exclusivity in the USOn 23 December 2018, Camurus announced that the US FDA had issued Braeburn a tentative approval of Brixadi™ for the treatment of moderate-to-severe opioid use disorder in patients who have ini-tiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. With the tentative approval, Brixadi™ has met all regulatory standards of clinical and non-clinical safety, efficacy and quality for US approval. However, a final approval of a monthly depot is according to the FDA subject to the expiration of an exclusivity period granted to Sublo-cade™. The restriction period ceases in November 2020, but both the scope and duration could potentially be reduced if successfully challenged.

product candidates in clinical developmentCAM2038 for the treatment of chronic painChronic pain represents a significant, global health problem and causes deterioration in general health, decreased capacity for work and reduced quality of life and, following medication with strong opi-oids, may cause opiod dependence. In the US, chronic pain is esti-mated to affect approximately 116 million people.61) The associated societal costs, including the costs of healthcare and lost productivity, are estimated at about 560-635 billion USD annually.62) In Europe, it is estimated that one in every five adults suffers from chronic pain, corresponding to around 100 million people.63) Worldwide, the corre-sponding figure is estimated at 1.5 billion people.64)

CAM2038 is a subcutaneous injection depot of buprenorphine that is developed to provide durable, round-the-clock pain relief

60) At book value.61) Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and

Research. National Academies Press, 2011.62) Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and

Research. National Academies Press, 2011. 63) Breivik H, et al. Eur J Pain. 2006;10:287-333.64) Global Industry Analysts, Inc. Report, 2011.65) Decision Resources Chronic Pain report 2016.66) Salinas GD, et al. J Pain Res. 2012;5:363-9.67) The Joint Commission and the FDA take steps to curb adverse events related to the use and misuse of opioid drugs. ED Manag. 2012;24:112-116.68) Dahan A, et al. 2005;94:825-34.69) Tompkins DA, et al. J Pharmacol Exp Ther. 2014;348(2):217-26.

without the risks associated with treatment with morphine, oxyco-done, fentanyl and other full opioid agonists. CAM2038 allows high and stable buprenorphine exposure and can, therefore, be used for patients who need high opioid doses, equivalent to 40 mg/day or more of morphine. Subcutaneous administration by a healthcare professional once weekly or once monthly is expected to increase compliance and reduce the risks of incorrect use. Thus, CAM2038 could provide the combination of long-lasting efficacious analgesia with the reduced risk of misuse, abuse, illicit diversion and overdoses associated with full mu-opioid receptor agonists, such as morphine, oxycodone and fentanyl.

Background: chronic painChronic pain is often defined as pain lasting longer than 3 months or beyond the normal time for tissue healing. Common types of chronic pain include lower back pain, arthritis, headache, and face and jaw pain. Moderate pain may prevent a person from participating in their daily activities, while severe pain typically stops a person from partici-pating in those activities and prompts them to exhibit pain-avoidance behavior. Chronic pain management is one of the most difficult clinical challenges in medicine today, with limited treatment options available and a high unmet medical need.

The global market for chronic pain exceeded 23.3 billion USD in 2014, with the US market accounting for about half of the market at 15.4 billion USD.65) More than one quarter of the market is from opioid analgesics.

Current treatments and their limitationsOpioids are recommended for the management of moderate to severe acute and chronic pain that cannot be adequately controlled by means of non-opioid analgesics. Based on the need for extended pain relief, many extended-release opioid products exist on the market in the form of tablets and patches, which are typically based on full opioid agonists, such as morphine, oxycodone and fentanyl. These products are widely used for the treatment of chronic pain, but are also associated with limited compliance, over-dosage, misuse, abuse, and diversion.66), 67)

With the aim of optimizing pain therapy with opioids, the World Health Organization (WHO) recommends keeping plasma opioid concentrations as stable as possible to ensure long-acting, effective and lasting pain relief, and thereby improved quality of life.

Buprenorphine is an effective analgesic with a potency at least 30 times that of morphine. Dose-dependent pain relief has been observed with intramuscular doses of up to 10 mg, and in parallel, respiratory depression is minimized since buprenorphine is a partial mu-opioid receptor agonist and exhibits a ceiling on some opioid effect.68) Clinically, buprenorphine also has a less significant effect on gastrointestinal activity, resulting in a lower incidence of constipation compared with full mu-opioid receptor agonists. In addition, the slow dissociation of buprenorphine from the receptors results in an extended effect and minimizes withdrawal symptoms upon discon-tinuation of therapy.69)



Buprenorphine is currently available in injectable formulations to treat moderate to severe acute pain (e.g. Temgesic® and Buprenex®) and transdermal patches for chronic pain (e.g. BuTrans®/Norspan® and Transtec®). These products provide stable but relatively low buprenorphine concentrations over a period of 7 and 4 days, respec-tively. As with tablets, patches are associated with compliance issues, abuse, misuse and diversion, and are also limited by relatively low plasma concentrations, which results in an inadequate analgesic effect for patients requiring high opioid levels.70)

CAM2038 – a new treatment alternative for chronic painThe development focus for CAM2038 in chronic pain has been on transferring pain patients, who are being treated with opioids at morphine-dose equivalents of 40 mg/day or more, to buprenorphine. CAM2038 may offer these patients a safer treatment option that reduces the exposure to dangerous, high-dose opioids. Commer-cial synergy with the opioid dependence indication for CAM2038 (Buvidal®) is expected, as pain is often a part of the opioid depen-dence problem and vice versa, and for both indications there are significant unmet needs for products that can improve treatment adherence and effectiveness as well as reduce the risks of misuse and diversion. A label in both indications (opioid dependence and pain) for CAM2038 would allow more effective treatment of these overlapping patient populations. Notably, CAM2038 has the potential to provide continuous round-the-clock therapy, resulting in improved pain relief, increased convenience and enhanced quality of life, particularly for patients looking for an alternative treatment to high-dose opioids.

Clinical resultsCAM2038, both as weekly and monthly buprenorphine depots, has been evaluated in a Phase 3 efficacy trial in opioid experienced patients with chronic low-back pain. The trial successfully met its primary efficacy endpoint of average pain intensity (API) demon-strating that patients with chronic low-back pain receiving treatment with CAM2038 experienced a statistically significant reduction in pain compared with patients treated with placebo (p<0.001). Furthermore, the key secondary endpoint of worst pain intensity also demonstrated statistical significance (p<0.001). The additional secondary endpoints were supportive of the main results. Following completion of the randomized efficacy part of the Phase 3 study, the long-term safety of CAM2038 is being evaluated in a 52-week, open-label extension study, in which patients either are continuing from the randomized efficacy part of the study or are included directly in the open-label extension study phase.

Weekly and monthly CAM2038 have also been studied in a Phase 2 study in opioid dependent patients with moderate to severe non-cancer chronic pain. The results confirmed the target weekly and monthly dosing intervals for the CAM2038 depots, showing extended buprenorphine release with dose dependent steady-state trough concentrations in the 2–3 ng/mL range. Pain and opioid with-drawal scores continued to be well controlled after transitioning from sublingual buprenorphine to CAM2038 in the study.71)

Further developmentCamurus is currently awaiting outcomes for the open-label extension study and intends to discuss both efficacy and safety outcomes with the European Medicines Agency (EMA) to determine the registration

70) BuTrans® Prescribing Information, June 2014.71) Camurus data on file.72) Pavel M, et al. Cancer Chemother Pharmacol. 2018;Dec 8. Epub ahead of print.73) Pavel M, et al. Cancer Chemother Pharmacol., 2018;Dec 8. Epub ahead of print.

of CAM2038 for the treatment of chronic pain. Marketing authoriza-tion application submissions are currently planned for the first half 2020.

CAM2038 for the treatment of moderate to severe chronic pain in opioid-tolerant patients is being developed in collaboration with Braeburn Pharmaceuticals who has exclusive rights to North America.

CAM2029 for the treatment of acromegaly and neuroendocrine tumorsCAM2029, formulated with Camurus’ patented FluidCrystal® injec-tion depot technology, contains the active pharmaceutical ingredient octreotide. Octreotide is a synthetic peptide analogue of the natural peptide hormone somatostatin used for treatment of acromegaly and NET. The current market leading somatostatin analogue (SSA) product Sandostatin® LAR® needs to be reconstituted in several steps before intramuscular injection by healthcare professionals. CAM2029 comes in a pre-filled syringe equipped with an automatic needle-stick prevention device and can easily be injected subcutane-ously, also by the patient themselves, without the need for complex reconstitution before administration. CAM2029 has also been demonstrated to be compatible with auto injectors, which could fur-ther enhance the ease of administration. Furthermore, CAM2029 has a about 500 percent higher bioavailability compared to the market leading product Sandostatin® LAR®, which potentially could improve treatment efficacy for patients not responding satisfactory to current therapies.72)

CAM2029 has been evaluated in four clinical Phase 1 and 2 trials and has demonstrated positive results with regards to pharmacoki-netics, pharmacodynamics and safety. Positive results from a Phase 2 multicenter trial in patients with acromegaly or NET were recently published, including well maintained or improved biochemical control in patients with acromegaly and symptom control in patients with functioning NET after switch from Sandostatin® LAR®.73)

In July 2018, Camurus regained the global development and commercialization rights to CAM2029 and related assets from Novartis. Novartis, who had been responsible for the development of CAM2029 since October 2013, decided to return the rights due to commercial reprioritization among its different programs. According to Novartis, the decision did not reflect a change in the view of the development of CAM2029.

The design of a pivotal Phase 3 trial with CAM2029 for the treat-ment of acromegaly is finalized, and the protocol is currently under-going a “Special Protocol Assessment” process at the US FDA. The purpose of the process is to obtain feedback from the FDA and to reach an agreement on the final design of the Phase 3 trial, which is planned to start during mid-2019.

Background: acromegaly and NETAcromegaly is a rare and chronic hormonal disorder that occurs when the pituitary gland produces excess growth hormone. The dis-ease is insidious, and more than 90% of cases are due to the hyper-secretion of growth hormone in a benign pituitary tumor (pituitary adenoma). Acromegaly most commonly affects middle-aged adults with an equal distribution between genders and it occurs in most ethnic groups Acromegaly is associated with reduced quality of life, shortened life expectancy and an increased prevalence of cardio-vascular mortality risk factors. The clinical symptoms of acromegaly



include progressive skeletal growth and soft tissue enlargement, mainly of the extremities (hands and feet) and head. The prevalence of acromegaly in the US and Europe is estimated to be around 8 per 100,000,74),75),76) thereby meeting the orphan disease prevalence cri-teria. The annual incidence rate in these regions has been estimated to 2 to 11 cases per 1,000,000 people. According to DelveInsight’s, the total prevalence in the US, EU and Japan is expected to reach 65,337 cases in 2027 compared to 60,610 cases in 2016.77)

NET (previously termed carcinoids) are a heterogeneous group of rare and malignant neoplasms that originate from regulatory hor-mone-producing neuroendocrine cells that can arise throughout the body. Depending on their histology and primary origin, these tumors can secrete various bioactive amines and hormones, causing the classical carcinoid syndrome of diarrhea, flushing and sometimes wheezing. Most NET are malignant, commonly metastasizing to lymph nodes and the liver. They can remain asymptomatic for years, presenting at a relatively late stage with symptoms of mass effect or distant (usually hepatic) metastases. Although functioning tumors result in distinct syndromes, individual symptoms are commonly non-specific, often leading to a delay in diagnosis of several years (5–7 years on average) and increasing the probability of metastatic disease.78) The incidence rate of NET has significantly increased in recent years and is now estimated to be seven per 100,000 per year, with an estimated prevalence of 54 per 100,000 in the US.79)

Current treatment and their limitations Surgery is the most effective option to achieve a rapid and complete cure of both acromegaly and NET. However, for most patients, where surgery is not possible, pharmacological therapy with the SSAs octreotide and lanreotide is the standard treatment option. SSAs have an effective normalizing impact on growth hormone and IGF-1 in about 55% of patients with acromegaly, while about 40% of NET patients experience therapeutic effects for carcinoid syndrome in the form of reduced flushing and diarrhea.80) Later studies have shown that SSAs also have tumor reducing effects.81),82)

Three different SSAs are currently approved for the treatment of acromegaly or NET: • octreotide, in Sandostatin® and Sandostatin® LAR® from Novartis • lanreotide, in Somatuline® LA® and Somatuline® Autogel® from

Ipsen • pasireotide, in Signifor® LAR® from Novartis.

In addition, generic versions of the immediate release version of oct-reotide (Sandostatin®) are available on several markets.

Sandostatin® LAR® is a long-acting depot of octreotide admin-istered once-monthly as an intramuscular injection. The product requires refrigeration and must therefore be conditioned to room temperature before administration. Due to its complex reconstitution procedure and the need for intramuscular injection, Sandostatin® LAR® requires administration by a specially trained healthcare professional.

Somatuline® Autogel® is a depot formulation of lanreotide for deep subcutaneous injection once a month. Due to the high viscosity of the product, the custom-made syringe has a relatively thick needle

74) Lavrentaki A, et al. Pituitary. 2017;20(1):4-9.75) Burton T, et al. Pituitary. 2016;19(3):262-7.76) Broder MS, et al. Endocrine practice: official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists. 2016;22(11):1327-35.77) Acromegaly: Market Insights, Epidemiology and Market Forecast-2027, DelveInsight 2018.78) Modlin IM, et al. Lancet Oncol. 2008;9:61-72.79) Acromegaly: Market Insights, Epidemiology and Market Forecast-2027, DelveInsight 201880) Modlin IM, et al. Aliment Pharmacol Ther. 2010;31:169-88.81) Giustina A, et al. PLoS One. 2012;7:e36411.82) Caron PJ, et al. J Clin Endocrinol Metab. 2014;99:1282–90.83) GlobalData, 2019

and the injection time is long. In addition, it requires refrigeration and must be conditioned to room temperature before administration.

Signifor® LAR® is a relatively new, long-acting SSA based on pasi-reotide, which has a broader binding affinity to several somatostatin receptor subtypes. It is approved for the treatment of acromegaly, but due risks of serious side-effects and a black box warning because of the risk of increased blood glucose levels, the uptake has been relatively limited and it is used as a second-line medical treatment.

Camurus is not currently aware of any other SSA depot formu-lations in late-stage clinical development in Europe or the US. How-ever, Chiasma Pharmaceuticals is in Phase 3 development with an oral octreotide product candidate, Mycapssa®.

Market opportunityThe global market for leading SSA products Sandostatin® LAR® and Somatuline® Autogel® has more than quintupled over the past 15 years, with a compound annual growth rate of 13%. In 2018, the global market for these products was valued at 2.5 billion USD.83) Despite several patent expiries since 2010, the sales of Sandostatin® LAR® continued to rise steadily and no generic long-acting product has entered the market. In recent years, Sandostatin® LAR® has lost market share to Somatuline® Autogel®, probably due to the recently expanded indication label for the treatment of NET patients to include not only symptom control but also tumor control

1

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Increases in awareness and diagnosis rate of rare endocrine dis-orders have contributed to the market expansion. The acromegaly market in the US, EU and Japan is expected to grow from 848 million in 2016 to USD 1,088 million in 2027, corresponding to a yearly increase of 2.3%.84) Growth may be further strengthened by potential new therapeutic indications for SSA products. Such applications include diabetic complications such as retinopathy, nephropathy and obesity, polycystic kidney disease, and pancreatitis.85), 86), 87)

CAM2029 – a new treatment alternative for acromegaly and NET®

CAM2029 for the treatment of acromegaly has been granted orphan designation by the European Commission. This status is granted for medicines of significant benefit to patients with rare diseases. Obtaining orphan designation provides several benefits during prod-

84) Acromegaly: Market Insights, Epidemiology and Market Forecast-2027, DelveInsight 201885) Rai U, et al. 2015;152:98-110.86) Woon C, et al. BMC Nephrol. 2015;16:140.87) Jin K, et al. Dig Surg. 2015;32:196-207.88) Tiberg F, et al. Br J Clin Pharmacol. 2015;80:460-72.

uct development, such as scientific advice and protocol assistance, and additional market exclusivity once the medicine is approved.

CAM2029 is expected to simplify treatment for patients, by allowing easy self-administration and avoiding frequent and some-times long journeys to specialist clinics for injections, with the further potential of reducing healthcare costs and workloads for healthcare professionals. In addition, CAM2029 is expected to provide a faster initial and potentially improved treatment efficacy in certain groups of patients with acromegaly and NET.

Due to its thinner needle, injections of CAM2029 may be less painful than Sandostatin® LAR® and Somatuline® Autogel®, which use thicker 20- and 18/19-gauge needles, respectively. Furthermore, Sandostatin® LAR® requires multi-step reconstitution from a powder before administration as an intramuscular injection by a trained healthcare professional.

The image below shows a product design comparison.

NO RECONSTITUTIONCAM202910, 20 mg/0.5-1.0 mL

ready-to-useFluidCrystal® technology

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Somatuline® Autogel® Lanreotide60, 90, 120 mg/0.2-0.5 mLready-to-use/refrigerated≥ 30 min reconditioning

self-associated gel

Camurus believes that the many positive features of CAM2029 create a potential for the product, if approved, to capture a significant future share of the global SSA market.

Clinical resultsThe pharmacokinetic and pharmacodynamic profiles, as well as safety and efficacy of CAM2029, have been documented after administration of single and repeated doses of CAM2029 in three Phase 1 clinical trials in healthy volunteers and one Phase 2 trial in patients with acromegaly or NET. More than 260 subjects have received over 570 injections of CAM2029 in these trials, which have also included immediate release Sandostatin® and Sandostatin® LAR® as reference products.

Following administration, CAM2029 gives rapid and long-acting release of octreotide to therapeutic concentrations (see figure below). Compared to Sandostatin® LAR®, CAM2029 has been shown to provide about 500% higher bioavailability of octreotide. The difference in bioavailability is also reflected in the pharmacody-namic effects on the insulin-like growth factor 1 (IGF-1). The figure below on the right shows how a much faster suppression, and generally lower levels, of IGF-1 is obtained with CAM2029 than with Sandostatin® LAR®. Notably, IGF-1 is a well-established surrogate biomarker for treatment efficacy in patients with acromegaly.88)



The higher octreotide exposure achieved with CAM2029 may potentially improve efficacy in some patient populations with acro-megaly and NET, as well as potentially provide opportunities in other therapeutic areas. A Phase 2 trial in patients with acromegaly (N=7) or NET (N=5), indicated that switching from Sandostatin® LAR® to CAM2029 resulted in maintained or decreased IGF-1 levels in acromegaly patients (see figure below, left). In patients with NET, switching to CAM2029 resulted in maintenance or improvement of symptom control, as measured by flushing episodes and bowel movements, see figure below (right).89) Camurus has also performed simulations of octreotide, GH, and IGF-1 for CAM2029 based on published or own models and data. The work has been performed in order for Camurus to better predict anticipated effects of CAM2029 in phase 3.

Although CAM2029 demonstrates about 500% higher octreotide exposure and a faster and more powerful suppression of IGF-1, the safety profile after repeat doses of CAM2029 was found to be com-parable with that of Sandostatin® LAR®.90)

Further development and market registrationEnd of Phase 2 meetings have been held with both European and US health authorities, with alignment achieved on the registration programs for CAM2029 in acromegaly and NET. Camurus is plan-ning to initiate a Phase 3 clinical trial in acromegaly in mid-2019

89) Pavel M et al, Cancer Chemother. Pharmacol. 2018;Dec 8. Epub ahead of print.90) Tiberg F, et al. Br J Clin Pharmacol. 2015;80:460-72.

to assess the superiority of CAM2029 compared to placebo in maintaining biochemical response. A Special Protocol Assistance process is ongoing to align details on the study design with the FDA. The long-term safety, pharmacokinetics and patient satisfaction to CAM2029 will also be evaluated in the trial.

A Phase 3 clinical trial in patients with low or intermediate grade gastroenteropancreatic NET is designed to demonstrate superiority of CAM2029 to prolong progression free survival (PFS) compared to best available therapy (Sandostatin® LAR® or lanreotide ATG).

CAM2043 for the treatment of pulmonary arterial hypertensionCAM2043 is a novel, long-acting treprostinil formulation for subcu-taneous administration currently in development for the treatment of PAH. Based on Camurus’ proprietary FluidCrystal® technology, CAM2043 offers both convenience in terms of a single weekly dose, eliminating the need for infusion systems or nebulizers used with other treprostinil products, and a favorable pharmacokinetic profile, eliminating the need for daily dosing. Based on these features, CAM2043 has the potential to be a suitable therapy for patients over the full range of disease severities in PAH. CAM2043 could potentially also find use in the treatment of Systemic Sclerosis and Raynaud’s Phenomenon, where prostacyclins such as treprostinil

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Left: Time average IGF-1 concentration for acromegaly patients treated with Sandostatin® LAR® (Oct-LAR) and after switch to CAM2029. Right: Average number of symptoms per day for NET-patients during the dosing period after treatment with Sandostatin® LAR® (Oct-LAR, steady state) and after switch to CAM2029.



are considered as a promising treatment option but no products are currently approved.

Background: pulmonary arterial hypertensionPulmonary arterial hypertension (PAH) is a progressive and life-threatening disease, characterized by an increase in the pul-monary vascular pressure and resistance, vascular remodeling and cellular proliferation within the lung, which may lead to right ventric-ular failure and premature death. The disease is clinically defined by an elevated mean pulmonary arterial pressure of >25 mmHg at rest and with a pulmonary arterial wedge pressure of <15 mmHg. PAH is divided into four different functional classes based on the severity of the disease, see table below.91)

Classification of pulmonary arterial hypertension (PAH):

WHO func-tional class Symptomatic Profile

I Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope

II Patients with pulmonary hypertension resulting in slight limitation of physical activity. They are com-fortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope

III Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope

IV Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients’ manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity

The prevalence of PAH is approximately 15–50 cases per million. This equates to about 80,000 patients within the EU.92)

The early symptoms of PAH such as dyspnea, dizziness and fatigue, are often mild and similar to many other conditions, such as cardiovascular and respiratory disease. At rest, there are often no symptoms and no apparent signs of illness. As a result, time from symptom onset to disease diagnosis is on average more than 2 years. This means that PAH is often not detected until the disease is relatively advanced. Without pharmacological therapy, death by progressive right ventricular failure is common.

There are currently four pharmacological treatment classes for PAH available on the market: prostacyclins (e.g. treprostinil), endothelial receptor antagonists, phosphodiesterase type 5 (PDE-5) inhibitors and soluble guanylate cyclase stimulators. Prior to the introduction of these therapies, median overall survival was 2.8 years, with median 6-month survival in patients with functional class IV of PAH. The cause of PAH is related to several factors but may develop due to imbalances in the endothelial, nitric oxide and prosta-cyclin pathways.

91) Rich S.. Advances in Pulmonary Hypertension. 2002;1(1):3-8.92) Norman P. Expert Opinion on Orphan Drugs 2014;2 (11):1137-45.93) Buckley MS, et al.. Core Evid 2014; 9:71-80.94) GlobalData, 201895) Pulmonary Arterial Hypertension – Opportunity Analysis and Forecasts to 2026, GlobalData, 201796) GlobalData, 2018

Current treatments and their limitationsTreprostinil is a prostacyclin analogue, which mainly reduces the pul-monary arterial pressure (PAP) by vasodilation of the pulmonary and systemic vascular bed. This leads to an improved systemic oxygen transportation and increased cardiac output.

Treprostinil was first approved by the FDA in May 2002 as a subcutaneous infusion formulation marketed as Remodulin® for the treatment of PAH. Treprostinil is now also available in the forms of intravenous infusion (Remodulin®), inhalation (Tyvaso®) and orally administered product (Orenitram®). All currently commercially avail-able products have a documented efficacy in PAH as assessed for example by the 6 minutes walking distance test. The best efficacy has been shown for parenteral (subcutaneous and intravenous) infu-sion products, but due to the complicated handling and the asso-ciated risks of serious bloodstream infections, and with infusion site reactions and pain, parenteral treprostinil is primarily used in patients with more severe PAH (WHO Functional Class IV).93) Factors such as poor bioavailability and variability of plasma concentrations, complex dosing schedules and handling of device, are limiting the use of oral and inhaled treprostinil to less severe cases of PAH (WHO FC I-III).

To Camurus’ knowledge, there are no other long-acting injectable products in clinical development for PAH. There are two other for-mulations of treprostinil in clinical development. SteadyMed (a wholly owned subsidiary of United Therapeutics Inc) is in registration phase for their single-use pump device and Liquidia is in Phase 3 develop-ment with their inhaled treprostinil product. Arena pharmaceuticals is developing a new prostacyclin receptor agonist, ralinepag, and is expected to complete Phase 3 in 2022. In addition, there is one combination treatment in Phase 3 development for PAH by Lung Biotechnology/United therapeutics, which combines esuberaprost (oral administration) with Tyvaso®.

Market opportunityThe four classes of products currently approved for the treatment of PAH include 13 approved products. The global market for PAH exceeded USD 5 billion in 2017.94) Future growth is expected, with the major growth drivers being the launch of new drugs, reimburse-ment support and an increased use of combination therapies.95) The US is the largest market with more than 50% of the global sales. Furthermore, there is great potential for the market to grow with the rising awareness of treatment options for PAH.

The global annual sales of the three commercially available tre-prostinil products (Remodulin®, Tyvaso® and Orenitram®), amounted to USD 1.2 billion in 2017.96)



CAM2043 – a new treatment alternative for PAHCAM2043 has the potential to offer once-weekly subcutaneous dosing without the risk of infusion-related infections and pump-re-lated complications and an improved quality of life for patients alleviated from the burden of carrying the extracorporal pump. With its product design, CAM2043 may be a treatment alternative not only

to infusion products but also oral and inhaled products, by providing consistent drug exposure and convenient once-weekly self-admin-istration by patients in a home setting. Based on this, CAM2043 has the potential to be a suitable therapy for patients across all functional classes of PAH.

36

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Based on the favorable product profile, CAM2043 may take market share from current parenteral, oral and inhaled therapy.

Clinical resultsThe pharmacokinetics and safety of CAM2043 have been evaluated in a Phase 1 trial in 60 healthy subjects. Single doses of CAM2043 showed dose proportional extended release of treprostinil in the dose range of 1–10 mg, see figure below.

The PAH market by pharmacological treatment class (left) and global sales development of commercially available treprostinil products.

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The tolerability of CAM2043 was generally acceptable with no observations of unexpected or serious adverse events. Injection site reactions were acceptable and resolved over time.

Further developmentCamurus is currently planning two Phase 2 trials with CAM2043; one in patients with PAH and one in patients with Raynaud’s Phe-nomenon secondary to systemic sclerosis. The trial in patients with PAH is planned to be an open-label, flexible-dose trial enrolling patients wishing to switch from their current treprostinil treatment to CAM2043. The trial will assess efficacy, pharmacokinetics, safety and tolerability of CAM2043. The trial in patients with Raynaud’s Phenomenon secondary to systemic scleroderma is planned to be an exploratory trial, enrolling a small number of patients.

CAM2032 – Flexible treatment of advanced prostate cancerThe well-established hormone therapies for prostate cancer, based on gonadotropin releasing hormone (GnRH) agonists such as leuprolide, aim to reduce testosterone levels and thereby impede the growth of cancer cells. Long-term treatment with GnRH agonists results in symptomatic improvement and the regression of prostate tumors in most patients. In comparative clinical trials on patients with metastatic prostate cancer, such treatment has proven to deliver comparable survival rates to surgical castration. GnRH agonists have also proven to be efficient in the treatment of other diseases, such as precocious puberty and endometriosis.

CAM2032 is a long-acting subcutaneous leuprolide depot for the treatment of prostate cancer. Based on Camurus’ FluidCrystal® injection depot technology, CAM2032 is being developed for self-ad-ministration with a pre-filled syringe as a small dose volume which does not require any reconstitution or temperature conditioning.

The market for GnRH agonists is dominated by long-acting injection products and has remained stable for some time, with total global annual sales of USD 3–4 billion.97) However, the established products are not suitable for self-administration and require prepa-ration by healthcare professionals prior to administration. Designed to enable self-administration, CAM2032 can provide patients with increased flexibility, while reducing the burden of scheduled injec-tions by healthcare professionals.

CAM2032 has being evaluated in two clinical Phase 2 studies; one single-dose study including 27 patients with prostate cancer and one repeated-dose study including 51 patients with prostate cancer. Both studies demonstrated pharmacokinetic and pharmacodynamic

97) GlobalData, 2018.98) Chemotherapy-Induced Nausea and Vomiting Market: Global Opportunities and Forecast 2014-2022, Allied Market Research 2017.99) Haiderali et al, Support Care Cancer. 2011 Jun;19(6):843-51.

profiles, i.e. the release of therapeutic levels of leuprolide and the reduction in testosterone levels, in accordance with the target prod-uct profile for a month by administration. The figure below shows the pharmacokinetic profile of leuprolide following repeated dosing of CAM2032 compared to the active control product Eligard®. The treatment effect, assessed by the suppression of testosterone and prostate specific antigen (PSA) levels over time, was found to be similar between the two treatments.

CAM2032 also demonstrated a favorable safety profile with good local tolerability. Discussions with potential development and com-mercialization partners are ongoing.

CAM4072 for the treatment of genetic obesityBased on Camurus’ FluidCrystal® technology, CAM4072 is a weekly formulation of the melanocortin 4 (MC4) agonist setmelanotide which is being developed by the company’s partner Rhythm Pharmaceuti-cals for the treatment of rare genetic obesity disorders. The FDA has granted Rhythm’s setmelanotide Breakthrough Therapy designation for the treatment of pro-opiomelanocortin (POMC) and leptin recep-tor (LepR) deficiency obesity and Orphan Drug Designation for the treatment of Prader-Willis Syndrome. Rhythm Pharmaceuticals has also received PRIority MEdicines (PRIME) designation for setmela-notide in Rare Genetic Disorders of Obesity from the EMA.

Results from Phase 2 clinical trials of setmelanotide demon-strated significant reductions in hyperphagia and body weight for patients with POMC and LepR deficiency obesity. Phase 3 clinical trials with a daily setmelanotide formulation are ongoing in both indications, while the long-acting formulation of setmelanotide, CAM4072, is being developed in parallel. Rhythm has success-fully completed Phase 1 studies of single and repeated doses of CAM4072 and further clinical studies of CAM4072 in patients with rare genetic obesity disorders are currently ongoing and being prepared.

CAM2047 for the treatment of chemotherapy-induced nausea and vomitingNausea and vomiting are among the most distressing side effects of chemotherapy, experienced by many cancer patients each year. The global chemotherapy-induced nausea and vomiting (CINV) market is expected to reach 2.7 billion USD in 2022. 98) The total cost associated with the development of CINV has been estimated at nearly 800 USD per patient for the first 5 days of the first cycle of chemotherapy.99)

38

0,01

0,1

1

10

100

0 14 28 42 56 70 84

leup

rolid

e ko

nc. (

ng/m

L)

Tid (dagar)

CAM2032 3.75 mgCAM2032 7.5 mgEligard 7.5 mg

0,01

0,1

1

10

100

0 14 28 42 56 70 84

leup

rolid

e co

nc (n

g/m

L)

Time (days)

CAM2032 3.75 mgCAM2032 7.5 mgEligard 7.5 mg

Mean leuprolide plasma concentration after repeated monthly dosing of CAM2032 vs. comparator drug Eligard (Phase 2 data).



Granisetron is a 5-HT3 receptor antagonist used for the treatment of acute CINV. Based on Camurus’ proprietary FluidCrystal® technol-ogy, CAM2047 is being developed as a long-acting subcutaneous depot providing prolonged exposure of granisetron for the treatment of acute and delayed CINV. Results from a Phase 1 trial assessing the safety and pharmacokinetic profile after single dose adminis-tration of CAM2047 demonstrated that the product candidate was well tolerated locally and systemically, with pharmacokinetic profiles meeting the target specifications.

39

0,1

1

10

100

0 1 2 3 4 5 6 7

Gra

nise

tron

plas

ma

konc

(ng/

mL)

Tid (dagar)

CAM2047 12.8mgCAM2047 20mg

0,1

1

10

100

0 1 2 3 4 5 6 7

Gra

nise

tron

plas

ma

conc

(ng/

mL)

Time (days)

CAM2047 12.8mgCAM2047 20mg

Mean granisetron plasma concentration after single doses of CAM2047 (Phase 1 data).

Discussions with potential development and commercialization part-ners are ongoing.

CAM2048 and CAM2058 for the treatment of acute pain and post-operative nausea and vomitingPost-operative pain and post-operative nausea and vomiting are common adverse effects after surgery. Many patients receive inad-equate pain therapy, which can lead to delayed mobilization and recovery, reduced pulmonary function, cardiac complications, and an increased likelihood of developing neuropathic pain.100) Opioid therapy is among the most effective treatments for postoperative pain, and buprenorphine offers a superior safety profile compared with full opioid agonists.101)

Based on Camurus’ proprietary FluidCrystal® technology, CAM2048 is being developed as a buprenorphine depot, providing rapid onset of action and sustained plasma levels of buprenorphine for the treatment of post-operative pain. CAM2058 is a unique com-bination of buprenorphine and granisetron, which not only addresses post-operative pain, but also the symptoms of nausea and vomiting that often co-occur with the pain.

Results from a Phase 1 trial of CAM2048 and CAM2058 demon-strated that the products were well tolerated locally and systemically, with pharmacokinetic profiles meeting the target specifications for these product candidates. Planning of the registration program and analysis of market potential is ongoing.

CAM2048 and CAM2058 are being developed in collaboration with Braeburn Pharmaceuticals.

Additional early stage collaborations In addition to the clinical stage development projects being con-ducted by Camurus both in-house and under collaboration agree-ments, the company also has several projects in the pre-clinical evaluation phase in collaboration with various international biotech and pharmaceutical companies. These collaborations include both clinical and marketed, patented active ingredients, where Camurus’ project can be part of the life-cycle management, and entirely new

100) Gan TJ, et al. Currt Med Res Opin. 2014;30(1):149-60. 101) Khanna IK, Pillarisetti S. J Pain Res. 2015;8:859-75.

active ingredients where FluidCrystal® technology is included in the product development strategy from the start of clinical development. Aside from co-funding Camurus’ R&D of its technologies and further boosting the company’s knowledge, these collaborations may also result in new collaboration and licensing agreements with possibil-ities of significant future revenues in the forms of development and sales milestones and royalties on future product sales. Camurus is currently performing several feasibility studies assessing partner drug compounds formulated with FluidCrystal® technology.

Preclinical in-house pipeline Camurus’ early stage product pipeline comprises a number of prom-ising internal product candidates in preclinical development, based on the FluidCrystal® technology. The evaluation and selection pro-cess of new product candidates uses a set of key criteria, including: • the possibility of fulfilling an important unmet medical need; • technology matching; • expeditious clinical development and market registration process; • the possibility of market exclusivity, including patent protection;

and • attractive markets.

Furthermore, development and commercial synergies with Camurus’ other projects and future commercial interests are also taken into consideration.

If the selection criteria are met, the product candidate is evalu-ated in preclinical studies against the target product profile in terms of drug loading, manufacture, stability and drug release in vitro and in vivo. Only once this preclinical evaluation is deemed successful does planning and initiation of the clinical development program, and tech-nology transfer for manufacturing of the product candidate, begin.

New products are usually protected by existing technology pat-ents and supplemented by additional product-specific patent appli-cations. An initial freedom-to-operate analysis is normally conducted when the product candidate’s properties have been identified; preliminary market analyses take place early in the project and are refined during clinical development.

research and development strategy R&D is a key strategic priority for Camurus. The company’s long-term success is largely dependent on its continued innovation and development of new and enhanced technologies and products that improve treatment outcomes and the quality of life of patients, while reducing the burden on the healthcare system.

Camurus’ R&D organization comprises pre-clinical, pharmaceu-tical and analytical, and clinical and regulatory development units. In 2014, Camurus invested in an additional new analytical laboratory with capacity for both advanced pharmaceutical analysis and bioanalysis.

New product ideas and development come from a deep under-standing of the different possibilities offered by Camurus’ technology platforms and from interaction with external stakeholders. The input from these sources is complemented by scientific documentation and market assessments to evaluate attractive product candidates and development projects. New development projects are aimed at solving medical problems within indication areas that can be addressed by Camurus’ development organization and/or commer-cial capabilities and that also have significant global market potential.

In addition to candidates identified in-house, new development projects come from other biotech and pharmaceutical companies. In



these cases, Camurus assesses whether the project is of strategic interest and then conducts a feasibility study, where key properties of the target product profile are evaluated, prior to entering into a more extensive clinical collaboration in the form of, for example, collabora-tion and licensing agreements.

Assessments of in-house ideas and feasibility studies for third parties typically include formulation optimization, stability assess-ment, the determination of in vitro and in vivo release profiles, and a basic toxicology evaluation. Depending on this assessment, Cam-urus or its partner may initiate clinical trials.

All R&D units at Camurus are involved in the preparation and exe-cution of early clinical trials. The company’s technical operation func-tion is responsible for technology transfers of manufacturing under good manufacturing practice (GMP) to one of Camurus’ contracted manufacturers of investigational medical products. Provided positive clinical results are achieved, in terms of, for example, pharmacoki-netics and safety, the project may proceed to a late development phase including the preparation and execution of pivotal trials (Phase 3 trials) for market registration (based, for example, on advice from the EMA and FDA) and the transfer of manufacturing to a commercial scale. Depending on the disease area, size and costs of the clinical program, and the market dynamics, Camurus may engage a part-ner in parts of or the full late-stage clinical development. However, usually the company retains rights to in-house projects for as long as possible to maximize the increase in value. When entering into a cooperation agreement, the agreement is structured to utilize the specific expertise of the respective partners to the greatest extent possible.

Following registration submission and approval, Camurus evalu-ates possibilities for conducting post-marketing studies and initiating life-cycle planning.

medical device – episil®The medical device episil® has been developed and registered by Camurus. episil® is a lipid-based liquid that is sprayed over the oral mucosa and immediately transforms into a strongly bioadhesive film protecting the sore and sensitized mucosa. The product has been studied in several clinical trials that have demonstrated positive treat-ment outcomes for, among other conditions, mouth pain in cases of oral mucositis, and episil® has been registered and launched in the US, EU and Japan.

Oral mucositisOral mucositis is a painful inflammation and ulceration of the oral mucosa. It is a frequent side effect of radiotherapy and chemother-apy, affecting nearly all head and neck cancer patients receiving radiotherapy and 30–75% of patients undergoing chemotherapy for other cancer types, including breast cancer. In severe cases, oral mucositis may be treatment limiting, necessitating a reduction in dosage or delays in the delivery of therapy. Furthermore, oral mucositis can in advanced stages be extremely painful, preventing the patient from eating and requiring hospitalization for re-hydration, opioid analgesia and total parenteral nutrition. Destruction of the pro-tective mucous membrane may further place the patient at a serious risk of infection.102)

102) Al-Ansari S, et al. Curr Oral Health Rep. 2015;2:202–11.103) Svanberg A, et al. Support Care Cancer. 2010;18:S114-5.104) Tiberg F, et al.. Support Care Cancer. 2009;17:918.105) Patient information leaflet (PIL) for episil®.

episil®

Despite the development of various medications and targeted thera-peutic interventions for the treatment of oral mucositis, a substantial medical need remains for effective pain control and mitigation of the symptoms of the disease. episil® has been developed to reduce pain in the oral cavity and can thereby maintain the patient’s ability to eat and drink and potentially reduce the need for total parenteral nutrition and opioid analgesics.103)

The product is based on Camurus’ FluidCrystal® topical bioadhe-sive technology. Clinical trials on cancer patients with oral mucositis have demonstrated that the lipid film, which is formed a few minutes after administration of episil®, strongly adheres to the mucosal sur-faces and thereby providing protection. In clinical trials, episil® has been demonstrated to rapidly reduce intraoral pain by an average of about 40% in cancer patients treated for head and neck cancer with radiation treatment, with a long-lasting effect of up to 8 hours.104) episil® has been shown to be well-tolerated with no systemic effects and very good local tolerability.105) episil® has obtained 501(k) market approval from the FDA in the US and a CE marking (class 1) in the EU. Camurus is ISO 13485:2016-certified, thereby ensuring that the applicable quality requirements for the design and manufacture of episil® are met.

episil® is currently marketed in Europe, the US, the United Arab Emirates, Japan and Australia. Its sales and distribution are conducted through several distribution partners, including Solasia Pharma KK and its distribution partner Meiji Seika Pharma in Japan, and through Camurus’ own sales efforts in Sweden, Denmark and the UK. Recently, episil® was also approved in China by the National Medical Products Administration (NMPA, formerly CFDA).

Ip rightsCamurus has an active IP rights strategy and strives to effectively maximize the protection of its inventions, technologies, products and product candidates with patents in all major pharmaceutical markets. The company has made numerous innovations, resulting in more than 330 patents providing an extensive geographical coverage. Camurus’ patents cover its technologies, products and product can-didates. Patent families for technologies includes WO2005/117830 for FluidCrystal® injection depot and WO2006/075123 for Fluid-Crystal® topical bioadhesive; and for product candidates includes WO2006/075124 for CAM2029, WO2014/016428 for CAM2038 and WO2018/050864 for CAM2043. In addition to maximizing the protection of the company’s technologies and product candidates, Camurus’ patent strategy aims to also allow the licensing of products to major pharmaceutical companies in specific product areas without losing overall control of the company’s core IP assets.



Camurus’ material patents for the FluidCrystal® technologies and various pharmaceutical candidates for main markets are set out in the table below.

Technology/ ProductPublication Number (US & EP and/or International)

Geographical scope granted/pending Expiry

USEurope

(EPO & national) RoWUS

(predicted) EPO/FluidCrystal® injection depot US8236292, EP1768650 2/2 13/0 16/0 2027 2025

US8097239, EP2052716 1/0 12/0 0/1 2028 2028US8865021, EP1682091 1/0 16/0 1/0 2028 2024WO2010/020794, EP2328552 1/1 11/0 2/0 2031 2029

WO2013083460US9585959EP2787975

1/0 16/0 6/7 2032 2032

WO2012160213 0/1 0/1 10/16 (2032) 2032WO2018/060212 – – 0/2 (2037) 2037

FluidCrystal® topical bioadhe-sive

EP2206495 US9649382 US9968680

3/0 12/0 0/0 2025 2025

FluidCrystal® nanoparticles US9060935, WO2006077362 1/0 0/1 7/0 2029 2025US8182834, EP1713446 1/0 83/0 0/0 2027 2025US8187629 1/0 3/0 0/0 2026 2025

Buvidal®/Brixadi™ US8236292US8236755US8545832

3/0 13/0 16/0 2027 2025

WO2014016428 US9937164

1/1 0/1 9/16 2032 2033

CAM2029 US8871712, EP1843746 1/0 11/0 4/0 2027 2025WO2008152401US9974861

1 1 7/1 2029 2028

WO2012160213 0/1 0/1 10/16 (2032) 2032

WO2018/060213 – – 3/0 (2037) 2037CAM2043 WO2018/050864 – – 1/0– 2037/(2038)CAM2032 US20090170782, EP1845942

US97574611/1 20/0 2/0 2025 2025

WO2010/020794, EP2328552 1/1 11/0 2/0 2031 2029CAM2047/CAM2058 WO2017/046384 0/1 0/1 0/10 2037CAM4071 WO2013/174978 0/1 0/1 1/6 (2033) 2033episil® US8920782

EP18484031/0 8/0 3/1 2030 2025

Camurus utilizes advanced research to develop innovative and differ-entiated technologies and products that provide significant value for patients and healthcare systems. R&D require substantial resources and efficient patent management to ensure adequate patent protection to capitalize on the future value of the technologies and products by establishing an exclusive market position. Camurus has built long-standing relationships with leading international IP firms to be able to efficiently protect its developments, and to maintain and defend its existing patents and trademarks, and ultimately the com-mercial value of the company’s various commercial assets.

manufacturing Camurus’ manufacturing strategy is based on partnerships and outsourcing, where in-house knowledge and expertise are combined with external contractors’ best practices, process experience, infrastructure and production capacity. Camurus has established a network of preferred contract manufacturing partners in both Europe and the US to support its manufacturing needs, ranging from the supply of small batch sizes of investigational medicinal products to large-scale commercial product supply. Camurus has substantial experience of technology transfers to contract manufacturers and has through such collaborations manufactured several products for commercial use as well as materials for clinical trials. Furthermore, Camurus has established a full supply chain for all key components and ingredients, and a commercial distribution network in Europe and Australia.



organizational overviewCamurus’Group structure:

Camurus’ Executive Management, R&D and Commercial.

Cubosome IncUSA

Camurus DevelopmentSweden

Camurus IncUSA

Camurus OyFinland

Camurus GmbHGermany

Camurus LtdUK

Camurus ABNorway

Camurus SASFrance

Camurus ABSweden

Nasdaq ”CAMX”

Camurus Pty LtdAustralia

Finance & ITEva Pinotti-Lindqvist

Investor RelationsFredrik Tiberg, Ph.D

Human ResourcesCecilia Callmer

Technical OperationsTorsten Malmström, Ph.D

Corporate Development & General Counsel

Urban Paulsson

BD & AlliancesFredrik Johansson, Ph.D

Commercial Operations & Marketing

Richard Jameson

CEO Fredrik Tiberg, Ph.D

R & DFredrik Tiberg, Ph.D

Clinical & RegulatoryDevelopment

Agneta Svedberg



As of 31 January 2019, Camurus had 100 employees, and an addi-tional 26 consultants – 12 in the commercial organization and 14 in R&D and HQ support functions.

No. of permanent employees 31 Jan 2019 2018 2017 2016At the end of period 100 94 71 62Women/men 54/46 51/43 39/32 37/25

Camurus’ head office is located at the Ideon Science Park in Lund, Sweden. The company’s premises consist of approximately 2,000 m2 of offices and laboratories. The division of employees by function is depicted below:

HQ Kommersiellt, 5

CEU, 16

NEU, 10

ROW (Australien, Frankrike, Spanien), 7

Kommersiella organisationen

Supportfunktioner, 6

F&U inkl Medical Affairs, 52

Tech Ops & Supply, 9

Kommersiella organisation 33

Anställda uppdelade per funktion

HQ Commercial, 5

CEU, 16

NEU, 10

ROW (Australia, France, Iberia), 7

Commercial organization

Support functions, 6

R&D incl. Medical Affairs, 52

Tech Ops & Supply, 8

Commercial organization, 33

Employees per function

SustainabilitySocial and environmental sustainability are vital aspects of Camurus’ Code of Conduct and the way the company operates, ensuring its long-term success for the benefit of patients. The third goal of the United Nations Sustainable Development Goals is to “Ensure healthy lives and promote well-being for all at all ages”. At Camurus, everybody works towards this goal through the mission to improve the lives of patients suffering from serious and chronic conditions by providing innovative treatment solutions. In the effort to develop new pharmaceutical products, a broad range of internal and external stakeholders, including employees, healthcare professionals, reg-ulatory authorities, payers and supply chain partners are engaged. Clear, effective and transparent communication with stakeholders is essential for ensuring sustainability throughout the entire value chain. Social responsibility at Camurus focuses on three main areas: employee wellbeing, patient safety and business ethics.

Camurus’ single greatest asset is its employees. The company does its utmost to provide a secure and safe workplace and a pos-itive working environment. Guidelines and procedures have been implemented to integrate health and safety aspects in all business activities, and to prevent employees from being exposed to unnec-essary risks.

Patient safety is Camurus’ highest priority. Internal guidelines and procedures have been implemented to protect patient safety and to ensure the high quality of products. Furthermore, all relevant laws and regulations in governing R&D, manufacture, storage and dis-tribution activities, including the disclosure of information regarding the safety of the company’s pharmaceutical products are followed. Any side effects related to compounds in clinical development as required by relevant laws and regulations are reported. Products

already on the market are tracked and monitored for side effects and new and unexpected safety signals. The company notifies regulators about relevant data in accordance with applicable regulations.

Camurus operates within a strictly regulated industry. Govern-ment regulatory bodies routinely demand information through audits, evaluations and inspections. Camurus’ employees are committed to upholding the highest standards of integrity and honesty and adhering to all relevant laws and guidelines regarding interactions with regulatory bodies and healthcare professionals. Services of healthcare professionals or organizations are utilized when there is a justifiable need. Compensation, if relevant, is in line with local legisla-tion. Clinical research to evaluate the safety and efficacy of medicines is a crucial component of pharmaceutical development. Camurus is committed to protecting the patients and healthy volunteers who participate in clinical trials, upholding the highest ethical, scientific, and clinical standards in all research, and communicating clinical trial results in a timely, accurate and transparent way. All data from clinical research is registered, processed and stored in a manner that facil-itates thorough reporting, interpretation and verification. Camurus is committed to providing accurate and non-misleading information about its products. The company’s Code of Conduct guides efforts against corruption and bribery. Suppliers play an important role in research, development and pharmaceutical sales. Camurus selects its suppliers based on objective criteria with the expectation that they act in a manner that corresponds to the company’s commitment to adhering to relevant laws and ethical business practices.

To protect the environment, Camurus strives to continually reduce waste and energy consumption, and to minimize the environ-mental impact of R&D work and products. Environmentally friendly ingredients and transportation are chosen whenever possible, and regional supply chains are established wherever practicable.



Industry and market informationThis prospectus contains certain industry and market information sourced from third parties, including statistics and data from industry publications and other publicly available information. Even if the information has been accurately reproduced and Camurus considers the sources reliable, Camurus has not independently verified the information and, accordingly, cannot provide any assurances as to its accuracy and completeness. As far as Camurus is aware and can ascertain by comparison with other information published by these sources, no information has been omitted that could render the reproduced information inaccurate or misleading.

pharmaceutical development and regulatory overviewDevelopment process for pharmaceuticalsIn order to obtain authorization for marketing of a pharmaceutical product, the developer must carry out extensive studies and comply with a rigorous regulatory framework. The studies are divided into pre-clinical studies and clinical trials.

Discovery phaseNew pharmaceuticals are typically discovered through one of the following steps: • new insights into a disease process that allow researchers to

design a product to stop or reverse the effects of the disease; • a broad range of tests of molecular compounds to find possible

beneficial effects against diseases; • existing treatments that have unanticipated effects; • new technologies that for example provide new ways to target

pharmaceutical products to specific sites within the body or new ways to manipulate genetic material.

Once researchers identify a promising compound for development, they commence experiments to gather more information about the product and its effects through pre-clinical studies.

Pre-clinical studies and preparations for clinical trialsBefore testing a compound on humans, the developer must inves-tigate whether there is a risk that the compound can lead to serious harm or toxicity. Pre-clinical studies using laboratory trials and human models evaluate the product’s chemistry, toxicity and formulation.

To proceed with clinical trials in humans in the US, the developer must make an investigational new drug (IND) application to the FDA, which includes the results of the pre-clinical studies, manufacturing information, analytical data, any available clinical data or literature data, and the proposed protocols of the clinical trials that are to be conducted. The clinical trial may be initiated 30 days after the IND application, unless the FDA has raised questions or concerns related to the clinical trials during that time period. In such case, the drug developer or sponsor must handle these issues and amend the application before the clinical trials can begin.

Pharmaceutical product development in the EU and the Euro-pean Economic Area (EEA) is subject to regulations by authorities at both EU and national levels. Clinical trials in the EU must be conducted in accordance with EU and national regulations, as well as with Good Clinical Practice (GCP). Any interventional clinical trials that are conducted in the EU/EEA, as well as clinical trials conducted outside the EU/EEA that are linked to European pediatric-medicine development, must be registered with the EU Clinical Trials Database (EudraCT).

Clinical trials In a clinical trial, a pharmaceutical product is administered to humans under the supervision of qualified investigators in accordance with GCP requirements. A clinical protocol must be submitted to the relevant supervisory authority, including the purpose of the trial, what parameters are to be used in monitoring safety, and the effectiveness criteria to be evaluated. An independent ethics committee or insti-tutional review board consisting of scientists and non-scientists in hospitals and research institutions will also review and approve the clinical trial plan from an ethical perspective. Informed written con-sent is required from all trial participants.

Human clinical trials are typically conducted in three or four sequential phases, which may overlap or be combined. The different phases are: • Phase 1: usually conducted on healthy volunteers but can also

involve patients with the target disease. The goal is to determine how the product is tolerated and how it is absorbed, distributed, metabolized and excreted. The initial doses are often low and may gradually be increased. Phase 1 trials can also yield important information about the product’s pharmaceutical effects. The number of subjects typically range from 20 to 80 people.

• Phase 2: aims to obtain preliminary data on whether the product is efficacious in patients with the targeted condition and establish an appropriate dosage for later large-scale testing of the product. Safety aspects are continuously monitored and short-term side effects are studied. The number of subjects typically range from a few dozen to about 300 patients.

• Phase 3: only commences if Phase 2, or in some cases Phase 1, results are promising, i.e. if evidence of efficacy and safety is obtained. Phase 3 trials gather further information to document safety, tolerability, statistically significant treatment efficacy, and different populations and dosages. Sometimes the product is studied in combination with other pharmaceuticals. In controlled trials, patients receiving the product are compared with patients receiving a different treatment, usually an inactive substance (pla-cebo), or a different authorized pharmaceutical in a double-blind randomized model. The number of subjects typically range from a few hundred to a few thousand patients.

• Phase 4: also called post-marketing surveillance studies as they are typically conducted after the trials required to obtain product approval. If the relevant supervisory authority, such as the FDA or European Commission, approves the application for market authorization of the new product, it may condition the approval with undertakings for the market authorization holder to conduct additional clinical trials after the receipt of approval. A developer may also voluntarily conduct additional trials, in order to get more information about the product’s long-term effects and health eco-nomic aspects.

During clinical trials, reports on the participants’ safety must be submitted to the authorities at least annually and more often if major adverse events occur. If it is found that the research subjects are being exposed to unacceptable health or safety risks, the clinical trial can be suspended or terminated by the authority at any time.

The developer of the pharmaceutical product must also develop a process for product manufacturing in commercial quantities in accordance with current Good Manufacturing Practice requirements. It is important that the manufacturing process is capable of con-sistently producing the product with high quality and that there are methods for testing the identity, strength, quality and purity of the final product. In addition, appropriate packaging must be selected and evaluated, and stability studies performed in order to demon-strate that the product does not undergo unacceptable deterioration over its shelf life.



regulatory overview Approval process The regulatory framework for development and receipt of marketing authorization for pharmaceutical products is extensive. Authorities regulate areas including research, development, testing, manu-facturing, safety surveillance, efficacy, quality control, packaging, storage, recordkeeping, labeling and the reporting of safety and other post-marketing information of the pharmaceutical product. Advertising, promotion, distribution, marketing, sales, import and export is also regulated. Before a pharmaceutical product can be sold and promoted, it must be approved by the national authority in the relevant country or region.

US regulations In the US, pharmaceutical development and marketing is regulated under the Federal Food, Drug and Cosmetic Act (FDCA) and federal, state and local regulatory authorities. The FDCA’s regulations contain requirements for the research, testing, development, manufacture, quality control, safety, effectiveness, approval, labeling, storage, record keeping, reporting, distribution, import, export, advertising and promotion of pharmaceutical products. Failure to comply during the review process or after receipt of marketing authorization may result in a variety of administrative or judicial sanctions, including refusal from the FDA to approve pending new drug applications (NDAs), withdrawal of an approval, product recalls, total or partial suspensions of production or distribution, injunctions, refusals of government contracts, disgorgement or civil or criminal penalties.

Under the provisions of section 505(b)(2), an NDA can rely on data not developed by the sponsor itself. These provisions of section 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved (‘referenced’ or ‘listed’) product. A 505(b)(2) NDA contains full safety and effec-tiveness reports but allows some of the information required for NDA approval, such as safety and efficacy information on the active phar-maceutical ingredient, to come from studies not conducted by or for the sponsor. This way, the traditional steps of formula development and extensive non-clinical studies may largely be avoided, and the clinical program may be reduced to fewer trials, including at least one Phase 3 trial. As a result, the route to an approval may be less expensive and faster compared with a traditional development path.

Regulations within the EU/EEAIn the EU/EEA, a marketing authorization (MA) is required before a pharmaceutical product can be placed on the EU market. The MA application is submitted for assessment to the EMA or the national authority. An MA is initially valid for 5 years and can be renewed based on a re-evaluation of the risk-benefit balance.

An MA issued through the centralized procedure gives the mar-keting authorization holder (MAH) access to all member states of the EEA. In this instance, the MA application must be submitted to the EMA for a scientific evaluation to be conducted.

An MA issued through the decentralized procedure or the mutual recognition process is based on the mutual recognition by national authorities. If the pharmaceutical product has not been granted an MA in any member state within the EEA at the time of application, the applicant can, through the decentralized procedure, submit an application in all member states where it intends to obtain an MA at the same time. One of the member states must be chosen as a reference member state where the main assessment will be made. If the pharmaceutical product has already received an MA in a member state at the time of application, the member states concerned must under the mutual recognition process recognize the MA granted by the reference member state.

An MA granted through the national procedure will give the MAH access to only one particular member state.

Data from pre-clinical studies as well as from clinical trials must be included in the application procedures, except when the application is made by the decentralized procedure or the mutual recognition process. If the applicant can demonstrate that the active substances of the pharmaceutical product have been in well-established medic-inal use within the EEA for at least 10 years, with recognized efficacy and an acceptable level of safety, the study and trial results may be replaced by appropriate scientific literature. There is therefore the possibility of a shortened development process for pharmaceutical product candidates where this so-called hybrid pathway is applica-ble, as the MA application can rely in part on pre-clinical and clinical data already submitted for a reference product.

Post-approval requirements Pharmaceutical products distributed or manufactured in accordance with an approval from the FDA or a national authority in the EEA or the European Commission, are subject to extensive and continu-ously updated regulations including record keeping, periodic safety reporting, product sampling and distribution, advertising and promo-tion and reporting of adverse experiences. The manufacturers must continue to spend time, money and effort on production and quality controls in order to ensure GMP compliance. If any non-compliance with regulatory requirements occurs or if there are other problems with the product, the authority may withdraw the approval.

If the developer seeks to modify the approved product, for exam-ple by adding new indications, a preview and approval of the change is required from the regulatory authority. In addition to this, there are annual user fee requirements for all marketed products, as well as new application fees for supplemental applications with clinical data. As a condition of approval for an NDA or MA, the FDA or the author-ity in the EEA may impose several post-approval requirements, such as additional testing, including Phase 4 clinical trials, and surveillance to assess and monitor the safety and effectiveness of the product.

In the US, manufacturers and others involved in the process must register their establishments with the FDA and relevant state author-ities and they may be subject to unannounced inspections by the FDA and the relevant state authorities, for evaluation of GMP compli-ance. If a deviation from GMP requirements occurs, the regulations require an investigation and correction of the deviation which in turn imposes reporting and documentation requirements.

The holder of an MA in the EEA must establish and maintain a pharmacovigilance system and appoint a qualified individual person who is responsible for the supervision of this system, who also has an extended duty to report suspected serious adverse reactions and to submit safety update reports. With regards to the advertising and promotional activities for the product, all off-label promotion and direct-to-consumer advertising of prescription pharmaceuticals is prohibited in the EU. In both EU/EEA and the US, an approved product must only be promoted for the approved indications and in accordance with the provisions of the approved label.

Non-compliance with the regulations or the discovery of previ-ously unknown problems with a product, including adverse events of unanticipated severity or frequency, may result in, for example, an obligation to add new safety information to the product, restrictions regarding the import or export of products, an obligation to conduct post-market studies or clinical trials, withdrawal of the product and/or injunctions or the imposition of civil or criminal penalties.



US regulation on controlled substances Brixadi™ contains buprenorphine, which is a controlled substance subject to extensive regulation under the US Controlled Substances Act of 1970 (CSA). The CSA and its implementing regulations estab-lish a framework through which the use of controlled substances for legitimate medical, scientific, research and industrial purposes is regulated. The regulations prevent the controlled substances from being diverted for illegal purposes.

Any person who handles controlled substances, for example pharmaceutical manufacturers, wholesale distributors and scientific researchers, must register with the Drug Enforcement Administration (DEA) in the US Department of Justice. Registrants must establish and maintain updated and complete records of all transactions involving controlled substances and detailed inventories of the substances in their possession, and periodically file reports with the DEA. In addition, they must ensure that controlled substances are securely stored and safeguarded in accordance with DEA reg-ulations. If a non-compliance with the CSA regulation occurs in the possession, manufacture or distribution of a controlled substances, criminal sanctions may apply.106)

EU regulation on the wholesale of pharmaceutical products, including narcotic substancesDirective 2001/83/EG establishes that all wholesale distributors of pharmaceutical products within the EEA need to apply for a permit with the national authority. A permit will be issued for the specified product if minimum requirements on premises, installations and security systems etc. are met. EU member states can apply more stringent rules in relation to narcotic substances on a national level.

As set out in the Directive, the European Commission has issued its Guidelines for Good Distribution Practice for pharmaceuticals for human use, 2013/C 343/01. These guidelines include rules on quality control and risk management, appointment of a responsible person within the wholesaling entity and other matters relating to employees, hygiene, premises, equipment, documentation, ware-housing, transport and return policies.

106) Yeh BT. The Controlled Substances Act: Regulatory Requirements. https|://www.|fas.|org/sgp/crs/misc/RL34635.pdf


Selected consolidated historical financial information

The below condensed financial statements (as well as measures defined under IFRS) pertaining to the full years 2016 and 2017 have been derived from Camurus’ annual reports for the financial years 2016–2017, which have been prepared in accordance with IFRS as they have been adopted by the EU and audited by the Company’s auditor. The condensed financial statements pertaining to 2018 have been derived from Camurus’ interim report for the period January–December 2018, which has been prepared in accordance with IAS 34 Interim Financial Reporting and the Swedish Annual Accounts Act (årsredovisningslagen (1995:1554)). The interim report has, as regards January–September 2018, been reviewed by the Company’s auditor. For further information on how reporting has been performed, reference is made to “Significant accounting principles” on p. 52 and onwards in Camurus’ 2017 annual report.

The prospectus also includes certain measures that are not defined under IFRS (alternative performance measures). These non-IFRS measures have not been reviewed or audited by the Company’s auditor. Camurus believes these measures are commonly used by certain investors, securities analysts and other interested parties as supplementary measures of performance trends and financial position. Camurus’ non-IFRS measures may not be comparable to other similarly titled measures presented by other companies and have certain limitations as analysis tools. Consequently, they should not be considered in isolation of, or as an alternative to, Camurus’ financial information prepared in accordance with IFRS.

The information below should be read in conjunction with “Operating and financial review” and Camurus’ annual reports for the financial years 2016–2017 and the interim report for the period January-December 2018, which have been incorporated by reference in this prospectus (see “Incorporation by reference, etc.” in “Legal considerations and supplementary information”). All financial statements are available on Camurus’ website, www.|camurus.|com.

Other than as stated above, no information in this prospectus has been reviewed or audited by the Company’s auditor.


S e l e C T e d C o n S o l I d AT e d h I S T o r I C A l f I n A n C I A l I n f o r m AT I o n

Condensed consolidated income statement

SEK thousand 2018 2017 2016Net sales 49,321 54,308 113,737Cost of sold goods –6,822 –1,356 –2,140Gross profit 42,499 52,952 111,597

Operating expensesMarketing and distribution costs –100,884 –45,893 –24,738Administrative expenses –21,999 –26,590 –17,985Research and development costs –207,664 –222,939 –172,077Other operating income 830 93 751Other operating expenses – –1,147 –Operating result –287,218 –243,524 –102,452

Result from financial itemsFinance income 175 174 95Finance expenses –25 –18 –1,002Net financial items 150 156 –907

Result before tax –287,068 –243,368 –103,359

Income tax 52,392 52,794 22,367Result for the year –234,676 –190,574 –80,993

Exchange-rate differences 46 16*) –Comprehensive income for the year –234,630 –190,558 –80,993Comprehensive income for the year is attributable to parent company shareholders.

Earnings per share based on earnings attributable to parent company shareholders for the year (in SEK per share)Earnings per share before dilution –6.20 –5.11 –2.17Earnings per share after dilution –6.20 –5.11 –2.17

*) As from the full year report for 2018, exchange-rate differences from conversion of subsidiaries outside of Sweden are reported under the item “Comprehensive income for the period”. Adjustments has been made accordingly for 2017, which has entailed that the exchange-rate differences for 2017 amounting to SEK 16 thousand has been moved, within consolidated equity from the item “Retained earnings” to the item “Comprehensive income for the period”. The items “Adjustment for non-cash items” and “Translation difference in cash flow and liquid assets” in the consolidated cash flow statement have been adjusted accordingly with SEK 16 thousand.



Condensed consolidated balance sheet

SEK thousand 31 Dec 2018 31 Dec 2017 31 Dec 2016ASSETSFixed assets

Intangible assetsCapitalized development expenditure 15,975 16,653 18,741

Tangible assetsEquipment 10,899 9,902 9,759

Financial assetsDeferred tax receivables 170,955 114,997 61,685Total fixed assets 197,829 141,552 90,185

Current assets

InventoriesFinished goods 4,700 724 2,187Raw materials 5,130 2,829 10,193

Current receivablesTrade receivables 2,280 5,781 8,304Other receivables 9,604 3,285 3,855Prepayments and accrued income 10,804 7,239 16,459Total current receivables 22,688 16,305 28,618

Cash and cash equivalents 134,377 314,524 508,594Total current assets 166,895 334,382 549,592TOTAL ASSETS 364,724 475,934 639,776

EQUITY AND LIABILITIESEquityEquity attributable to parent company shareholdersShare capital 960 932 932Other contributed capital 744,140 642,175 631,034Retained earnings, including comprehensive result for the period –492,776 –258,107 –67,549Total equity 252,324 385,000 564,418

LIABILITIES

Short-term liabilitiesTrade payables 35,781 15,086 17,560Income taxes 1,708 517 –Other liabilities 3,549 2,672 2,571Accrued expenses and deferred income 71,362 72,659 55,228Total short-term liabilities 112,400 90,934 75,358TOTAL EQUITY AND LIABILITIES 364,724 475,934 639,776



Condensed consolidated cash flow statement

SEK thousand 2018 2017 2016Operating activitiesOperating result before financial items –287,218 –243,524 –102,452Adjustment for non-cash items 4,450 4,088*) 3,524Interest received 175 174 95Interest paid –25 –18 –1,002Income taxes paid –272 0 –9,917Cash flow from operating activities before changes in working capital –282,890 –239,280 –109,752

Increase/decrease in inventories –6,277 8,827 –9,139Increase/decrease in trade receivables 3,501 2,523 613Increase/decrease in other current receivables –9,884 9,787 1,005Increase/decrease in trade payables 20,695 –2,474 –14,272Increase/decrease in other current operating liabilities 771 17,532 –76,242Cash flow from changes in working capital 8,806 36,196 –98,036Cash flow from operating activities –274,084 –203,084 –207,788

Investing activitiesAcquisition of intangible assets –1,404 – –Acquisition of tangible assets –3,357 –2,143 –4,567Cash flow from investing activities –4,761 –2,143 –4,567

Financing activitiesDirected share issue 92,741 – –Warrants issued 7,110 11,141 4,853Cash flow from financing activities 99,851 11,141 4,853

Net cash flow for the year –178,994 –194,086 –207,502Cash and cash equivalents at beginning of the year 314,524 508,594 716,096Translation difference in cash flow and liquid assets –1,153 –16*) –Cash and cash equivalents at the end of the year 134,377 314,524 508,594

*) As from the full year report for 2018, exchange-rate differences from conversion of subsidiaries outside of Sweden are reported under the item “Comprehensive income for the period”. Adjustments has been made accordingly for 2017, which has entailed that the exchange-rate differences for 2017 amounting to SEK 16 thousand has been moved, within consolidated equity from the item “Retained earnings” to the item “Comprehensive income for the period”. The items “Adjustment for non-cash items” and “Translation difference in cash flow and liquid assets” in the consolidated cash flow statement have been adjusted accordingly with SEK 16 thousand.



key operating metrics and data per share, the group

MSEK 2018 2017 2016Income statementNet sales1) 49.3 54.3 113.7Operating result2) –287.2 –243.5 –102.5Result for the period1) –234.7 –190.6 –81.0R&D costs as percentage of operating expenses (%)2) 63% 75% 80%

Balance sheetEquity2) 252.3 385.0 564.4Cash and cash equivalents2) 134.4 314.5 508.6Equity/assets ratio (%)2) 69% 81% 88%Total assets1) 364.7 475.9 639.8

Cash flowCash flow from operating activities2) –274.1 –203.1 –207.8

Data per shareAverage number of shares, before dilution1) 37,842,034 37,281,486 37,281,486Average number of shares, after dilution1) 39,231,356 38,058,289 37,487,937Earnings per share, before dilution (SEK)1) –6.20 –5.11 –2.17Earnings per share, after dilution (SEK)1) –6.20 –5.11 –2.17Equity per share, before dilution (SEK)2) 6.67 10.33 15.14Equity per share, after dilution (SEK)2) 6.43 10.12 15.06

OtherNumber of employees at end of period2) 94 71 62Number of employees in R&D at end of period2) 58 48 44

Measures for the interim period January–December 2018 are not audited.1) IFRS measure, audited.2) Non-IFRS measure, not audited.

definitions of IfrS measures

Measure Definition Reason for useNet sales Total sales proceeds relating to goods and services

less discounts, value added tax and other taxes attributable to the sales.

Camurus considers this measure to be relevant for keeping track of the development of the Group’s revenues.

Result for the period Net earnings, the Company’s profit or loss after taxes. This measure recognizes Camurus’ financial result for the period.

Total assets The Group’s total assets and liabilities respectively, as well as equity.

This measure recognizes Camurus’ total assets and liabilities respectively, as well as equity at the end of the period.

Average number of shares, before dilution

Average number of shares, before adjustment for dilution due to new shares.

Relevant when calculating the earnings per share, before adjustment for dilution.

Average number of shares, after dilution

Average number of shares, adjusted for dilution due to new shares.

Relevant when calculating the earnings per share, adjusted for potential dilution.

Earnings per share, before dilution (SEK)

Earnings divided by the average number of shares, before dilution.

This measure recognizes Camurus’ earnings per share, before potential dilution.

Earnings per share, after dilution (SEK)

Earnings divided by the average number of shares, adjusted for dilution.

This measure recognizes Camurus’ earnings per share, adjusted for potential dilution.



definitions of non-IfrS measures

Measure Definition Reason for useOperating result (EBIT) Profit/loss for the period before financial revenues,

financial costs and income tax on the result for the year.

Camurus considers that operating profit/loss (EBIT) recognizes the profit generated by the operating activities.

R&D costs as a percentage of operating expenses (%)

Research and development costs divided by oper-ating expenses (marketing and distribution costs, administrative expenses and research and develop-ment costs).

Camurus considers that this is a useful measure for recognizing what portion of the operating expenses that is attributable to research and development.

Equity Equity is the difference between the Group’s assets and liabilities. Refers to the Group’s own resources.

Camurus considers that equity recognizes the Group’s own resources.

Cash and cash equivalents Cash and cash bank balances. Camurus considers this to be a measure for how the Group can finance further activities and handle unex-pected costs.

Equity/assets ratio (%) Equity divided by total capital. Camurus considers this to be a measure for the Group’s long term solvency.

Cash flow from operating activities

Cash flow from operating activities after changes in working capital

Camurus considers that this measure recognizes the cash flow generated by the Company’s business activities.

Equity per share before dilution (SEK)

Equity divided by number of shares at end of period, before dilution.

Camurus considers that this measure recognizes the amount of the Group’s own resources per share, before adjustment for potential dilution.

Equity per share after dilution (SEK)

Equity divided by number of shares at end of period, adjusted for dilution.

Camurus considers that this measure recognizes the amount of the Group’s own resources per share, adjusted for potential dilution.

Number of employees at end of period

Number of employees at end of period (Compared with average number of employees according to IFRS)

Camurus is currently in an expansion phase and con-siders that this information is useful for keeping track of said expansion.

Number of employees in R&D at end of period

Number of employees mainly working within research and development at end of period

Camurus considers this to be a useful measure for recognizing what portion of the employees that is attributable to research and development.


operating and financial review

This operating and financial overview is provided to facilitate the understanding and assessment of trends and changes in the Company’s results and financial position. Historical results do not necessarily provide an accurate indication of future results. The information in this section should be read together with “Selected historical financial information” and the financial reports incorporated in this prospectus by reference (see “Incorporation by reference etc.” in “Legal considerations and supplementary information”).

January–december 2018 compared to January–december 2017Figures in parentheses refer to the corresponding period the previous year.

Net salesThe Group’s net sales amounted to SEK 49.3 (54.3) million, which is an increase of 9.2 percent. The net sales was generated from milestone payments and other revenues received under license agreements as well as from products sales. Other income, SEK 0.8 (0.1) million, was mainly generated from exchange gains.

CostsAccording to plan, the continued expansion of the commercial organization in, among other things, medical affairs, market access and marketing as well as the establishment of a subsidiary in Aus-tralia, preparations for the launch of Buvidal® in Europe and Australia including commercial manufacturing and distribution, and also clin-ical studies of Buvidal® in Australia, have entailed an increase of the Group’s costs for the year.

The Group’s marketing and sales costs during the financial year amounted to SEK 100.9 (45.9) million, which is an increase of 119.8 percent. Administrative expenses was SEK 22.0 (26.6) million, rep-resenting a decrease of 17.3 percent. Research and development costs amounted to SEK 207.7 (222.9) million, which is a decrease of 6.9 percent. Other expenses amounted to SEK 0 (1.1) million.

Results and returnThe operating result for the financial year was SEK –287.2 (–243.5) million, representing a deterioration in the result of 17.9 percent. The Group’s net financial items amounted to SEK 0.2 (0.2) million. Following an assessment of the parent company’s tax loss carry-forwards, a tax revenue of SEK 52.4 (52.8) million was recognized. The Group’s loss increased by 23.1 percent and amounted to SEK –234.7 (–190.6) million.

Cash flowCash flow from operating activities before change in working capital was negative and amounted to SEK –282.9 (–239.3) million, repre-senting an increased outflow by 18.2 percent. Change in working capital was positive and amounted to SEK 8.8 (36.2) million. Cash flow from investing activities amounted to SEK –4.8 (–2.1) million, and cash flow from finance activities amounted to SEK 99.9 (11.1) million related to a directed share issue and the issuance of warrants. Cash flow for the year was negative but improved by 7.8 percent and totaled SEK –179.0 (–194.1) million.

Financial positionThe Group’s cash position as of 31 December 2018 was SEK 134.4 (314.5) million. The change compared to the previous year mainly relates to the Group’s operating result. Consolidated equity was SEK 252.3 (385.0) million. Similar to in 2017, there were no outstanding loans as of 31 December 2018.

2017 compared to 2016Figures in parentheses refer to the corresponding period the previous year.

Net salesThe Group’s net sales amounted to SEK 54.3 (113.7) million, which is a decrease of 52.2 percent. The net sales was generated from license agreements as well as project related activities and product sales. The difference compared with the preceding year is mainly due to that the company’s revenue streams, from license and develop-ment milestones, varies from year to year. Other income during the year amounted to SEK 0.1 (0.8) million and was mainly generated from exchange gains.

CostsAccording to plan, the completion of the comprehensive pivotal clinical program of CAM2038 in opioid dependence, the continuous development of the early project pipeline and the expansion of the commercial organization in preparation of the planned launch of CAM2038 have entailed an increase of the Group’s costs for the year.

The Group’s marketing and sales costs during the financial year amounted to SEK 45.9 (24.7) million, which is an increase of 85.5 percent. Administrative expenses increased by 47.8 percent and amounted to SEK 26.6 (18.0) million for the year. Research and development costs amounted to SEK 222.9 (172.1) million, an increase of 29.6 percent. Other expenses amounted to SEK 1.1 (0.0) million.

Results and returnThe Group’s operating result for the financial year was SEK –243.5 (–102.5) million, representing an increased loss of 137.7 percent. The Group’s net financial items amounted to SEK 0.2 (–0.9) million. Following an assessment of the parent company’s tax loss carry-forwards, a tax revenue of SEK 52.8 (22.4) million was recognized. The Group’s loss increased by 135.3 percent and amounted to SEK –190.6 (–81.0) million.


o p e r AT I n g A n d f I n A n C I A l r e v I e w

Cash flowThe Group’s cash flow from operating activities before change in working capital was negative and amounted to SEK –239.3 (–109.8) million, representing an increased outflow by 118.0 percent. Change in working capital affected the cash flow positively by SEK 36.2 (–98.0) million. Cash flow from investing activities amounted to SEK –2.1 (–4.6) million, and cash flow from finance activities amounted to SEK 11.1 (4.9) million related to the issuance of warrants. Cash flow for the year was negative but improved by 6.5 percent and totaled SEK –194.1 (–207.5) million.

Financial positionThe Group’s cash position as of 31 December 2017 was SEK 314.5 (508.6) million. The change compared to the previous year mainly relates to the Group’s operating result. Consolidated equity was SEK 385.0 (564.4) million. Similar to 2016, there were no outstanding loans as of 31 December 2017.


Capitalization, indebtedness and other financial information

Capitalization and indebtedness, the groupCapitalizationSet forth below is Camurus’ capitalization as of 31 December 2018.

SEK thousand 31 December 2018Total current liabilities 112,400Guaranteed –Secured –Unguaranteed/unsecured 112,400Total non-current liabilities –Guaranteed –Secured –Unguaranteed/unsecured –Shareholders’ equity 252,324Share capital 960Other contributed capital 744,140Retained earnings, including profit for the period. –492,776

Net indebtedness, interest-bearingSet forth below is Camurus’ net indebtedness as of 31 December 2018.

SEK thousand 31 December 2018(A) Cash –(B) Cash equivalents 134,377(C) Trading securities –(D) Liquidity (A)+(B)+(C) 134,377(E) Current financial receivables –(F) Current bank debt –(G) Current portion of non-current debt –(H) Other current financial debt –(I) Current financial debt (F)+(G)+(H) –(J) Net current financial indebtedness

(I)-(E)-(D) –134,377(K) Non-current bank debt –(L) Bonds issued –(M) Other non-current loans –(N) Non-current financial indebtedness

(K)+(L)+(M) –(O) Net financial indebtedness (J)+(N) –134,377

working capital statementIt is Camurus’ assessment that the working capital is not sufficient for the present requirements during the next twelve months.

Camurus’ working capital requirements are mainly related to the continued development of the Company’s product candidates and the establishment of a commercial organization for the sale of Buvidal® on selected markets in Europe and Australia. The working capital is deemed to be sufficient for financing Camurus’ operations until May 2019 and the shortfall in working capital for the next twelve months is expected to be somewhere in the range SEK 300-350 mil-lion. The forthcoming rights issue is estimated to raise approximately

SEK 403 million before transaction costs. Considering that the rights issue is fully underwritten through subscription and underwriting commitments from existing shareholders and external guarantors, the Board of Directors’ assessment is that the conditions for a fully subscribed rights issue are very good. However, the subscription and underwriting commitments are not secured.

If the rights issue, despite the abovementioned subscription and underwriting commitments, does not raise a capital contribution of at least SEK 403 million and if Camurus does not succeed to gen-erate further revenues or to perform sufficient cost reductions, the Company may have to seek further external financing and postpone or terminate research and development activities. This can ultimately entail that the Group’s operations may have to be reduced.

research and developmentCamurus’ operations are based on research and development activ-ities and Camurus’ possibility to succeed in the long term is highly dependent on continuous success with innovation and development activities as regards new technologies and pharmaceutical products. Camurus’ research and development activities are further described in “Business and market overview”.

Due to the high level of risk associated with the Company’s devel-opment projects, all development work is treated as research until the point at which the product has been granted market approval (since the work does not meet the criteria for being recognized as an intangible asset before that point). Research expenditure is expensed as it occurs. Please also refer to note 14 on p. 66 in the 2017 annual report.

The table below shows Camurus’ research and development expenses during the financial years 2016–2018.

SEK thousand 2018 2017 2016Research and development expenses 207,664 222,939 172,077Total 207,664 222,939 172,077

InvestmentsThe table below summarizes the Group’s total investments for the financial years 2016–2018. The investments mainly consist of, with respect to tangible assets, laboratories and production equipment, and with respect to intangible assets, capitalised expenditure related to the ongoing clinical study in Australia.

SEK thousand 2018 2017 2016Tangible assets 3,357 2,143 4,567Intangible assets 1,404 – –Total 4,761 2,143 4,567

Current and future capital expendituresCamurus does not have any material current or future capital expen-ditures. The Company’s planned use of proceeds is described in “Background and reasons”.


C A p I T A l I z AT I o n , I n d e B T e d n e S S A n d o T h e r f I n A n C I A l I n f o r m AT I o n

Significant changes since 31 december 2018On 11 January 2019, Camurus announced that the European launch of the Company’s long-acting depot treatment of opioid depen-dence, Buvidal®, had been initiated and that the medicine is available for healthcare providers and patients in Finland and Sweden. On 6 February 2019, the Company announced its intention to carry out a rights issue on approximately SEK 403 million with preferential rights for the Company’s shareholders, subject to approval by the general meeting.


Board of directors, group management and Auditor

Board of directorsAccording to Camurus’ Articles of Association, the Board of Directors shall comprise of not less than three and not more than ten members elected by the shareholders at the general meeting. In addition and by law, employee organizations are entitled to appoint employee repre-sentatives. The Board of Directors currently comprises seven members elected by the general meeting (elected by the 2018 Annual general meeting for a term of office extending until the close of the 2019 Annual general meeting).

Name Assignment Elected IndependentAudit Committee

Remuneration Committee Share holding1)

Per-Olof Wallström Chairman 2010 Yes Member Chairman 77,748Per-Anders Abrahamsson Member 2006 Yes 33,561Marianne Dicander Alexandersson Member 2015 Yes Member 12,050Martin Jonsson Member 2013 No2) Chairman Member 22,682Kerstin Valinder Strinnholm Member 2015 Yes Member 19,928Fredrik Tiberg Member, CEO 2002 No3) 1,512,551Behshad Sheldon Member 2018 Yes –1) Own holdings and holdings of related persons and affiliated companies as at 31 January 2019 (and known changes thereafter).2) Not independent in relation to major shareholders.3) Not independent in relation to the Company and Group Management.

Per-Olof Wallström

Born 1949. Chairman of the Board since 2015 and Board member since 2010. Chairman of the Remuneration Committee and member of the Audit Committee.Principal education and professional experience: M.Sc. in Phar-macy from Uppsala University. CEO of Q-Med AB, Melacure AB and Karo Bio AB. Senior management at Merck Sharpe & Dohme, Astra Zeneca, Pharmacia and Bristol Myers Squibb.Other current assignments/positions: Board member of Arosia Communication AB and Q-linea AB.Previous assignments/positions (past five years): Chairman of the Board of AROSGRUPPEN Holding AB, Chemilia Aktiebolag, Masmästaren Fjärdingen AB, MB Erikssons Bygg & Fastighet AB, Nexttobe AB and Neodynamics AB (publ). Board member of Aggal Invest AB, Hansa Biopharma AB, Patients Pending Ltd and Mediplast AB. Deputy board member of Addcode Design AB.Holding: 77,748 shares.Independent in relation to the Company and Group Management as well as the Company’s major shareholders.

Per-Anders AbrahamssonBorn 1949. Board member since 2006.Principal education and professional experience: Doctor of Med-icine from Lund University, Ph.D., Professor of Oncological Urology. Chairman of the departments of Urology in Malmö and Lund and the department of Urology at Skåne University Hospital. Laboratory Director at the department of Urology at University of Rochester Medical Centre and Adjunct Professor at the University of Rochester, Medical Centre, New York. Secretary General of the European Asso-ciation of Urology.Other current assignments/positions: Chief Physician and Profes-sor Emeritus at the department of Urology, Lund University, Skåne University Hospital, Malmö. Board member of Cernelle AB, IDL Biotech AB, Medisport AB and Medisport Holding AB. Consultant for Prostatalund AB, Cernelle AB and IDL Biotech AB.

Previous assignments/positions (past five years): Associate Vice President, Medical Affairs, Ferring Pharmaceuticals A/S. Board member of GOAR Holding A/S.Holding: 33,561 shares.Independent in relation to the Company and Group Management as well as the Company’s major shareholders.

Marianne Dicander AlexanderssonBorn 1959. Board member since 2015. Member of the Audit Committee.Principal education and professional experience: M.Sc. in Chemical Engineering from Chalmers University of Technology. Many years of experience in the life science industry and from board work, including as CEO of Kronans Droghandel, Global Health Partner and the Sixth AP Fund, deputy CEO of Apoteket AB and positions within quality and market development at Pharmacia, Imperial Chemical Industries and Volvo.Other current assignments/positions: Chairman of the Board of Sahlgrenska Science Park AB and the Royal Swedish Academy of Engineering Sciences (IVA Väst) and Co-Chair of International Women Forum (IWF). Board member of Addera Care AB (publ), Enzymatica AB (publ), Praktikertjänst Aktiebolag, Promore Pharma AB (publ), Recipharm AB (publ) and Xperentia AB. Board member and CEO of MDA Management AB. Member of the council at Skan-dia and member of the Advisory Council of the Dental and Pharma-ceutical Agency.Previous assignments/positions (past five years): Board member of Castellum Aktiebolag (publ), West Atlantic AB (publ), Mölnlycke AB and Easy Lighting Scandinavia AB.Holding: 12,050 shares.Independent in relation to the Company and Group Management as well as the Company’s major shareholders.


B o A r d o f d I r e C T o r S , g r o u p m A n A g e m e n T A n d A u d I T o r

Martin JonssonBorn 1961. Board member since 2013. Chairman of the Audit Com-mittee and member of the Remuneration Committee.Principal education and professional experience: M.Sc. in Business Administration from Lund University. Over 25 years of com-bined experience in corporate management and working in senior positions in various industries such as medical devices, biotechnol-ogy and industrial kitchens.Other current assignments/positions: Chairman of the Board of Scandinavian Water Technology AB. Board member and CEO of Sandberg Development AB. Board member of ISEC Monitoring Sys-tems AB and Orbital Systems AB.Previous assignments/positions (past five years): Partner at Amadea Partnership.Holding: 22,682 shares.Independent in relation to the Company and Group Management, but not in relation to the Company’s major shareholders.

Kerstin Valinder StrinnholmBorn 1960. Board member since 2015. Member of the Remunera-tion Committee.Principal education and professional experience: Degree from the School of Journalism at the University of Gothenburg. Many years of experience in sales, marketing and business development from senior positions at Astra/AstraZeneca and Nycomed/Takeda.Other current assignments/positions: Board member of Klifo A/S, Corline Biomedical AB, Immunicum AB, KVS Invest AB, Gedea Bio-tech AB and Cavastor AB. Deputy board member of Pollux Pharma AB.Previous assignments/positions (past five years): EVP Business Development for the Nycomed Group.Holding: 19,928 shares.Independent in relation to the Company and Group Management as well as the Company’s major shareholders.

Fredrik TibergBorn 1963. Board member since 2002. CEO since 2003.Principal education and professional experience: M.Sc. in Chemical Engineering from Lund Institute of Technology. Ph.D. and associate professor in physical chemistry from Lund University, adjunct professor of surface chemistry at Lund University. Visiting professor of physical and theoretical chemistry at the University of Oxford. Head of Research at Camurus and visiting professor of physical chemistry at Lund University.Other current assignments/positions: Board member of Camurus Lipid Research Foundation. Member of the Royal Swedish Academy of Engineering Sciences (IVA).Previous assignments/positions (past five years): Board member of Medicon Valley Alliance.Holding: 1,512,551 shares and 205,000 warrants.Independent in relation to the Company’s major shareholders, but not in relation to the Company and Group Management.

Behshad SheldonBorn 1963. Board member since 2018.Principal education and professional experience: B.Sc. in Neu-roscience from University of Rochester. Extensive experience from various senior positions in international pharmaceutical companies, including Smithkline Beecham, Bristol-Myers Squibb and Otsuka Pharmaceuticals.Other current assignments/positions: Chairman of the Board of FORCE (Female Opioid Research and Clinical Experts) in Princeton, New Jersey.Previous assignments/positions (past five years): President and CEO of Braeburn Pharmaceuticals.Holding: -Independent in relation to the Company and Group Management as well as the Company’s major shareholders.

group management

Name PositionMember of Group Management since

Employed within Camurus since Shareholding1)

Holding of warrants1)

Fredrik Tiberg CEO 2003 2002 1,512,551 205,000Eva Pinotti-Lindqvist Chief Financial Officer 2014 2014 36,291 33,882Richard Jameson Chief Commercial Officer 2016 2016 16,395 120,000Agneta Svedberg Vice President, Clinical and Regulatory

Development 2015 2015 9,073 70,000Fredrik Joabsson Chief Business Development Officer 2011 2001 36,391 40,000Cecilia Callmer Vice President, Human Resources 2017 2017 – 26,000Torsten Malmström Vice President, Technical Operations 2013 2013 36,291 28,000Urban Paulsson Vice President Corporate Development

& General Counsel 2017 2017 6,500 115,0001) Own holdings and holdings of related persons and affiliated companies as at 31 January 2019 (and known changes thereafter).

Fredrik TibergCEO since 2003.See ”Board of Directors” above.

Eva Pinotti-LindqvistBorn 1963. Chief Financial Officer since 2014. Principal education and professional experience: M.Sc. in Business Administration from Lund University. More than 25 years of experience in Finance and more than 15 years of experience from the pharmaceutical industry, including as CFO and Vice President Business Development at EQL Pharma AB and Market analyst at

Nordic Drugs AB. Controller at Svedala Svenska AB and Finance Manager at Poseidon Yacht Charter AB.Other current assignments/positions: Owner of the sole propri-etorship (Sw. enskild firma) JOCE Häst & Hö.Previous assignments/positions (past five years): Board member of EQL Pharma OY. Deputy board member of EQL Pharma Int AB.Holding: 36,291 shares and 33,882 warrants.

Richard JamesonBorn 1964. Chief Commercial Officer since 2016. Principal education and professional experience: BSC (Hons) in Applied Biological Sciences from University West of England. More



than 20 years in the pharmaceutical industry including executive/senior positions in sales leadership, marketing, market access and general management for companies which include Serono, Schering Plough, Ferring and Indivior PLC.Other current assignments/positions: Board member of Glidebirth Ltd.Previous assignments/positions (past five years): Area Director Europe, Middle East and Africa at Indivior PLC.Holding: 16,395 shares and 120,000 warrants.

Agneta SvedbergBorn 1963. Vice President, Clinical and Regulatory Development since 2015. Principal education and professional experience: M.Sc. in radio-physics and Executive MBA, Executive Foundation Lund (EFL), B.Sc. in Medicine, all from Lund University. Over 25 years of experience in drug development, including as COO for Zealand Pharma A/S, CEO of Cantargia AB and Senior Vice President, Clinical Development at Genmab A/S.Other current assignments/positions: -Previous assignments/positions (past five years): COO for Zea-land Pharma A/S.Holding: 9,073 shares and 70,000 warrants.

Fredrik JoabssonBorn 1972. Chief Business Development Officer since 2019. Principal education and professional experience: Ph.D. in phys-ical chemistry and M.Sc. in chemistry from Lund University. Many years of experience in drug development through various positions in research and development and business development at Camurus.Other current assignments/positions: -Previous assignments/positions (past five years): -Holding: 36,391 shares and 40,000 warrants.

Cecilia CallmerBorn 1974. Vice President, Human Resources since 2017. Principal education and professional experience: Bachelor stud-ies in Psychology at Lund University and Copenhagen University, and Master studies in Psychology at Copenhagen University and Bond University. Many years of experience of Human Resources in international companies and more than ten years within the phar-maceutical industry, including positions at Novo Nordisk and Ferring Pharmaceuticals A/S.Other current assignments/positions: -Previous assignments/positions (past five years): -Holding: 26,000 warrants.

Torsten MalmströmBorn 1968. Vice President, Technical Operations since 2013. Principal education and professional experience: Ph.D. in chemistry from Lund University. Almost 20 years of experience in the pharmaceutical industry, including as Director Pharmaceutical Development for Zealand Pharma A/S, Director Development for Polypeptide and Team Manager at Astra Zeneca.Other current assignments/positions: -Previous assignments/positions (past five years): -Holding: 36,291 shares and 28,000 warrants.

Urban PaulssonBorn 1963. Vice President Corporate Development & General Coun-sel since 2017.

Principal education and professional experience: Master of Law from Lund University. More than 20 years of experience from the life science industry including as Legal Counsel at Pharmacia Corpora-tion, and General Counsel for Vitrolife AB. Former partner at law firms Bird & Bird and Nordia Law.Other current assignments/positions: Chairman of the Board of Buzzard Pharmaceuticals AB, Cavis Technologies AB, Cordivest AB, Gesynta Pharma AB and Molecules of Man AB. Board member of Nylof Holding AB and Urban Paulsson AB.Previous assignments/positions (past five years): Chairman of the Board of Axcentua Pharmaceuticals AB and Cormorant Phar-maceuticals AB. Board member of DermaEffect Sweden AB and Cinclus Pharma AG.Holding: 6,500 shares and 115,000 warrants.

other information concerning the Board of directors and group managementAll members of the Board and Group Management can be contacted via the Company’s address, Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden.

There are no family ties between any of the members of the Board of Directors and/or Group Management. No Board member or senior executive has been convicted in any case involving fraud-ulence during the past five years. None of them have been involved in any bankruptcy, receiverships or liquidation during the past five years in the capacity of a member of administrative, management or supervisory bodies or a senior executive. No incrimination and/or sanctions have been issued by statutory or regulatory authorities (including designated professional bodies) during the past five years against any of the members of the Board or Group Management. Nor, during the past five years, has any member of the Board or Group Management been disqualified by a court from acting as a member of the administrative, management or supervisory bodies of a company or from acting in the management or conduct of the affairs of any company.

In June 2018, there were reports in media that the Swedish Economic Crime Authority had initiated a preliminary investigation regarding gross market abuse against Per-Olof Wallström due to his acquisition of shares in the Company in the end of May 2018. The acquisition was made and reported in accordance with applicable laws and the Company’s internal policies and guidelines. As per the date of this prospectus, it has not been possible to confirm whether the media reports regarding a preliminary investigation are correct or not. Per-Olof Wallström has not been contacted by the Economic Crime Authority and Per-Olof Wallström has neither, when contacting the authority, been able to receive any information regarding the alleged preliminary investigation.

No member of the Board or Group Management has any private interests which might conflict with their duties to Camurus. How-ever, as stated above, a number of the members of the Board and Group Management have a financial interest in Camurus through shareholdings.

AuditorPricewaterhouseCoopers AB (Torsgatan 21, 113 97 Stockholm, Sweden) is the Company’s auditor since the Annual general meeting on 11 May 2015, with Ola Bjärehäll as auditor in charge since then. Ola Bjärehäll is an authorized public accountant and a member of FAR (the professional institute for authorized public accountants in Sweden).



Corporate governanceCorporate governance within CamurusThe governance of Camurus is based on Swedish law, Camurus’ Articles of Association, the Swedish Code of Corporate Governance (the “Code”) and Nasdaq Stockholm’s Rule Book for Issuers as well as other relevant laws and regulations. The Code is based on the “comply or explain” principle, meaning that companies are not obliged to at all times apply every rule in the Code, but are allowed the freedom to choose alternative solutions which they feel are better in their particular circumstances, provided they report every devia-tion, describe the alternative solution and explain the reasons for the deviation. Camurus applies the Code without any deviation.

Board CommitteesThe Board of Directors has established two committees, the Audit Committee and the Remuneration Committee.

The main duties of the Audit Committee are to supervise the Company’s financial reporting, monitor efficiency in its internal controls, internal audit and risk management, and apprise itself of information regarding the audit of the annual report and consolidated financial statements, review and monitor the auditor’s impartiality and independence and, in so doing, take particularly into account whether the auditor provides Camurus with services other than audit services. The Audit Committee shall also assist the Nomination Committee with proposal to the general meeting for election of audi-tors. The Audit Committee has regular contacts with the auditors of Camurus.

The Audit Committee comprises Martin Jonsson (chairman), Marianne Dicander Alexandersson and Per-Olof Wallström. The

Committee complies with the Companies Act’s requirements for independence and accounting and auditing expertise.

The main duties of the Remuneration Committee are to prepare decisions by the Board of Directors on issues concerning remuner-ation principles, remuneration and other employment terms for the CEO and other members of the Group Management, and to monitor and assess ongoing programs for variable remuneration to the Group Management, as well as such programs as have been com-pleted during the year. Furthermore, the Committee shall monitor and assess the application of the guidelines for remuneration to the executive management resolved by the annual general meeting, as well as applicable remuneration structures and remuneration levels in the Company.

The Remuneration Committee comprises Per-Olof Wallström (chairman), Martin Jonsson and Kerstin Valinder Strinnholm. The Committee is assessed to comply with the Code’s requirements for independence and appropriate knowledge and experience in ques-tions related to remuneration of executive management.

Compensation to the Board of DirectorsThe 2018 Annual general meeting resolved that a fee of SEK 550,000 shall be paid to the Chairman of the Board and a fee of SEK 200,000 to each other Board member who is not employed by Camurus. In addition, the general meeting resolved that a fee of SEK 100,000 shall be paid to the Chairman of the Audit Committee and a fee of SEK 50,000 to each other member of the Committee, while a fee of SEK 50,000 shall be paid to the Chairman of the Remu-neration Committee and SEK 25,000 to each other member of the Committee.

The table below specifies resolved fees payable to Board mem-bers elected by the general meeting during 2018.

SEK Function Board fee1)

Fee Audit Committee1)

Fee Remuneration Committee1) Total

Per-Olof Wallström Chairman 550,000 50,000 50,000 650,000Per-Anders Abrahamsson Member 200,000 – – 200,000Marianne Dicander Alexandersson Member 200,000 50,000 – 250,000Martin Jonsson Member 200,000 100,000 25,000 325,000Svein Mathisen2)3) Member 59,461 16,989 8,494 84,944Kerstin Valinder Strinnholm Member 200,000 – 25,000 225,000Fredrik Tiberg Member, CEO – – – –Behshad Sheldon4) Member 200,000 – – 200,000Totalt 1 609 461 216 989 108 494 1 934 9441) Refers to fees resolved by the 2018 Annual general meeting for the time until the Annual general meeting 2019. CEO Fredrik Tiberg does not receive any fee.2) Resigned from the Board at the Annual general meeting on 3 May 2018. Received a fee for the period 1 January-3 May 2018 amounting to SEK 84,944.3) Refers to fee for work within the Board, not including social security contributions, paid to the Board member’s company.4) Elected at the Annual general meeting in May 2018.

Compensation to Group ManagementThe compensation to members of Group Management comprises fixed salary, variable salary, pension benefits, other benefits and conditions for termination. The table below shows the compensation paid to the CEO and other members of the Group Management in 2018.

SEK thousand Fixed salary1) Variable salary Other benefits2) Pension benefits3) TotalPresident and CEO 4,899 1,617 87 1,488 8,091Other Group Management* 10,369 2,751 308 2,157 15,585Total 15,268 4,368 395 3,645 23,676

* 7 persons in 2018.1) In addition to the above agreed remuneration, earned and paid stay-on bonuses, in accordance with the terms in the warrant programs TO 2016/2019, TO 2017/2020 and TO

2018/2021, to CEO of SEK 1,012 thousand and to other senior executives of SEK 2,170 thousand, have been accounted for.2) Refers primarily to car benefits. 3) The Group Management’s pension plans are defined contribution plans. There are consequently no amounts set aside or accrued to provide pension, retirement or similar benefits to the

current Group Management.



Between Camurus and the CEO a notice period of 12 months applies in respect of the Company and 6 months in respect of the CEO. No severance payment will be made. In the event that the CEO’s employment in the Company is terminated due to or in connection with a transfer of the Company to a new owner, a 24 month notice period applies from the Company’s side. During the notice period the CEO is entitled to fixed monthly salary and other benefits in accordance with the current employment contract. If the employment contract is terminated by the Company, remuneration from the Company shall not be reduced by any other benefits as the CEO may receive during the notice period. Between the Company and other senior executives, a mutual notice period of three to twelve months applies. No severance payment will be made.


Share capital and ownership structure

Share informationAccording to Camurus’ Articles of Association, the share capital shall be not less than SEK 500,000 and not more than SEK 2,000,000, divided into not less than 20,000,000 shares and not more than 80,000,000 shares. There is only a single class of shares in the Company. As of 31 December 2018, the Company’s registered share capital was SEK 959,537.15, represented by 38,381,486 shares (37,281,486 shares as at 1 January 2018), each with a quota value of SEK 0.025. The shares in Camurus have been issued in accordance with Swedish law, are fully paid and denominated in SEK. The shares are not subject to any restrictions on transferability. The rights of the shareholders may only be changed pursuant to the procedures set out in the Swedish Companies Act (aktiebolagslagen (2005:551)).

No changes to the number of shares have occurred since 31 December 2018. The forthcoming rights issue will, if fully subscribed, result in an increase of the number of shares in the Company from 38,381,486 to 47,976,858 shares, representing an increase of 25 percent. For shareholders who decline to subscribe for shares in the rights issue, the shareholding will be diluted with a total of 9,595,372 new shares, representing approximately 20 percent of the total shares in the Company after the rights issue.

The shares in Camurus are not subject to any offer made pur-suant to a mandatory takeover bid and/or squeeze-out and sell-out rules. No public takeover bids have been made in respect of the shares in Camurus during the current financial or previous financial year.

Certain rights attached to the sharesGeneral meetingsNotice of general meetings shall be published in the Swedish Official Gazette (Post- och Inrikes Tidningar) and on the Company’s website. Simultaneously, an announcement with information that the notice has been issued shall be published in Svenska Dagbladet. To be entitled to participate in a general meeting, the shareholder must be registered in the share register five weekdays prior to the meeting, and notify the Company of the participation not later than on the day specified in the notice of the meeting.

Voting rightsEach share carries one vote. Each shareholder is entitled to vote for the total number of shares held without limitation of the voting powers.

Preferential rights to new shares, etc.Should the Company decide to issue shares, warrants or convert-ibles (Sw. konvertibler) by way of a cash issue or a set-off issue (Sw. kvittningsemission), shareholders shall have preferential rights to subscribe in proportion to their existing shareholdings. There are, however, no provisions in the Company’s Articles of Association that limit the Company’s ability to decide to, in accordance with the rules set out in the Swedish Companies Act, issue new shares, warrants or convertibles with deviation from the shareholders’ preferential rights.

Rights to dividends and surplus in the event of liquidationAll shares carry the same right to share in the Company’s profit and any surplus in the event of liquidation.

Dividends are resolved upon by the general meeting and the payment is administered by Euroclear Sweden. Dividends may only be paid if the Company, after such dividends, still has full coverage of its restricted equity and further to the extent that such dividends are justified taking into consideration (i) the demands with respect to size of shareholders’ equity which are imposed by the nature, scope and risks associated with the operations, and (ii) the Company’s and the Group’s consolidation needs, liquidity and financial position in general (the so-called prudence rule). As a general rule, the share-holders may not decide upon larger dividends than those proposed or approved by the Board of Directors. Dividends are normally paid to shareholders in cash on a per share basis, but may also be paid in kind. See also “Dividend policy” below.

On the record date established by the general meeting, holders recorded as owners of shares in the register of shareholders main-tained by Euroclear Sweden will be entitled to receive dividends. If a shareholder cannot be paid through Euroclear Sweden, such shareholder still retains its claim to the dividend amount, and the claim remains against the Company subject to a statutory limitation of 10 years. Should the claim become barred by the statute of limita-tions, the dividend amount is forfeited to the Company. Neither the Swedish Companies Act nor the Company’s Articles of Association contain any restrictions regarding dividend rights of shareholders outside Sweden. Subject to any restrictions imposed by banks or clearing systems in the relevant jurisdiction, payments to such share-holders are made in the same manner as for shareholders resident in Sweden. However, shareholders with limited tax liability in Sweden are normally subject to Swedish withholding tax. See “Certain tax issues in Sweden” for additional information.

Share capital developmentThe table below shows the development of the Company’s share capital since 1 January 2016.

Year EventChange in

number of sharesChange in share

capital, SEKTotal number

of sharesTotal share

capital, SEKQuota

value, SEKSubscription price,

SEK per share2018 New share issue 1,100,000 27,500 38,381,486 959,537.15 0.025 932019 Forthcoming rights issue 9,595,3721) 239,8841) 47,976,8581) 1,199,4211) 0.025 421) Assuming the rights issue will be fully subscribed.


S h A r e C A p I T A l A n d o w n e r S h I p S T r u C T u r e

ownership structureAs at 31 January 2019, Camurus had approximately 5,500 share-holders. The largest shareholder was Sandberg Development AB, with approximately 53.2 percent of the total share capital and voting rights in the Company. The table below shows the Company’s larg-est shareholders as of 31 January 2019.

Major shareholders as of 31 January 2019

Holder/nominee/custodianNumber of

sharesShares and

votes, %Sandberg Development AB 20,414,978 53.19Gladiator 2,495,000 6.50Fredrik Tiberg, CEO 1,512,551 3.94Fjärde AP-fonden 896,116 2.33Backahill Utveckling AB 877,193 2.29Catella Fondförvaltning AB 779,624 2.03Avanza Pension 732,749 1.91Swedbank Robur Fonder 706,456 1.84Camurus Lipid Research Foundation 445,000 1.16Grenspecialisten Förvaltning AB 372,721 0.97Total ten largest shareholders 29,232,388 76.16Other shareholders 9,149,098 23.84Total 38,381,486 100.0

Source: Euroclear Sweden.

Sandberg Development can exercise significant influence over the Company in matters where the shareholders have a voting right. Due to its shareholding, Sandberg Development may put through several proposals at a general meeting, even if other shareholders do not agree with the proposal. Sandberg Development is therefore able to exercise significant influence over Camurus. The control is, however, limited in accordance with the rules set out in the Swedish Compa-nies Act (2005:551) on minority protection.

In Sweden, the lowest limit for disclosure of holdings (so-called flagging) is five percent of all shares or the voting rights of all shares.

listing and share price performanceThe Camurus share is listed on Nasdaq Stockholm since 3 Decem-ber 2015. The share is traded on the Mid Cap list under the ticker CAMX.

AuthorizationsAt Camurus’ annual general meeting 2018, the Board of Directors was authorized to resolve on new issue of shares with or without deviation from the shareholders’ preferential right. The authorization may be exercised on one or several occasions up to the annual general meeting 2019, and a maximum of 3,728,149 shares may be issued. An issue may be made against cash payment, by set-off or by contribution in kind, and the issue rate shall, at deviation from the shareholders’ preferential right, be determined in accordance with market practice. The Board of Directors shall be entitled to determine other terms of the issue.

On 29 June 2018, the Board of Directors resolved to exercise part of the authorization granted by the annual general meeting by resolving on a directed share issue of 1,100,000 new shares. The issue entailed a dilution of approximately 2.9 percent of the share capital in relation to the number of shares in Camurus after the issue, through an increase in the number of outstanding shares by 1,100,000 from 37,281,486 to 38,381,486 and a share capital increase by SEK 27,500 from SEK 932,037 to SEK 959,537.

Shareholders’ agreements, etc.To the Board of Directors’ knowledge, there are no shareholders’ agreement or other agreements between shareholders in the Com-pany intended to exercise joint control of the Company. Neither is the Board of Directors aware of any agreements or similar which may cause changes to the control of the Company.

Share-based incentive programs, etc.Share-based incentive programsAt the 2016, 2017 and 2018 Annual general meeting, it was resolved to adopt incentive programs for the Company’s employees, including issue and transfer of warrants. The warrants have been valued by an independent institute in accordance with the Black&Scholes model and were acquired by the participants at market value. As part of the incentive programs, the participants receive a threepiece stay-on bonus in the form of gross salary addition from the company, which is conditional upon continued employment and equivalent to the amount paid by the participant for its warrants. The terms and con-ditions for the warrant programs, which are further described below, contain customary recalculation terms, including for preferential rights issues carried out before the time for exercise.

Warrant program 2016/2019At the Annual general meeting in May 2016 it was resolved to issue and transfer warrants to the Company’s employees under War-rant program 2016/2019. In total, the incentive program includes 550,000 warrants, which give the right to subscribe for an equal number of shares during the period 15 May 2019 – 15 December 2019. The dilution effect on a maximum utilization of subscribed warrants corresponds to 1.4 percent calculated as the number of new shares in proportion to the number of existing and new shares. The subscription price for subscription of shares upon exercise of the warrants was set at 99.50 SEK, which corresponds to 140 percent of the volume weighted average price paid for the Company’s share during the period from and including 18 May 2016 to and including 24 May 2016.

Altogether, 47 employees have chosen to participate in the program and in total subscribed for 404,300 warrants. No further allocation can be made under the program, which entails an actual maximum dilution effect corresponding to 1.1 percent.

Warrant program 2017/2020At the Annual general meeting in May 2017 it was resolved to issue and transfer warrants to the Company’s employees under War-rant program 2017/2020. In total, the incentive program includes 750,000 warrants, which give the right to subscribe for an equal number of shares during the period 15 May 2020 – 15 December 2020. The dilution effect on a maximum utilization of subscribed warrants corresponds to 2.0 percent calculated as the number of new shares in proportion to the number of existing and new shares. The subscription price for subscription of shares upon exercise of the warrants was set at 167.20 SEK, which corresponds to 140 percent of the volume weighted average price paid for the Company’s share during the period from and including 10 May 2017 to and including 16 May 2017.

Altogether, 44 employees have chosen to participate in the program and in total subscribed for 658,932 warrants. No further allocation can be made under the program, which entails an actual maximum dilution effect corresponding to 1.7 percent.


S h A r e C A p I T A l A n d o w n e r S h I p S T r u C T u r e

Warrant program 2018/2021At the Annual general meeting in May 2018 it was resolved to issue and transfer warrants to the Company’s employees under War-rant program 2018/2021. In total, the incentive program includes 1,000,000 warrants, which give the right to subscribe for an equal number of shares during the period 15 May 2021 – 15 December 2021. The dilution effect on a maximum utilization of subscribed war-rants corresponds to approximately 2.6 percent calculated as the number of new shares in proportion to the number of existing and

new shares. The subscription price for subscription of shares upon exercise of the warrants was set at 144.9 SEK, which corresponds to 140 percent of the volume weighted average price paid for the Company’s share during the period from and including 4 May 2018 to and including 11 May 2018.

To date, 47 employees have chosen to participate in the program and in total subscribed for 562,400 warrants, which entails an actual maximum dilution effect corresponding to 1.5 percent. Transfer of warrants to future employees is allowed until the Annual general meeting on 9 May 2019.

Total amountsThe table below shows the aggregate increase in number of shares and of the share capital as well as the dilution effect if all outstanding warrants are exercised (prior to any recalculation by reason of the upcoming rights issue and not taking into account actual allocation or sub-scription in the programmes).

ProgramNumber of

new sharesShare capital increase SEK

Dilution of shares and votes, %

Actual maximum dilution of shares and votes, %

Warrant program TO 2018/2021 1,000,000 25,000 2.6 1.5*Warrant program TO 2017/2020 750,000 18,750 2.0 1.7Warrant program TO 2016/2019 550,000 13,750 1.4 1.1Total 2,300,000 57,500 6.0 4.3* Under Warrant program TO 2018/2021, transfer of warrants to future employees may take place until the AGM 2019, which would entail further dilution.

Central securities depositoryThe Company’s shares are book-entry registered in a securities reg-ister in accordance with the Swedish Central Securities Depository and Financial Instruments Accounts Act (lagen (1998:1479) om vär-depapperscentraler och kontoföring av finansiella instrument). The register is operated by Euroclear Sweden (Euroclear Sweden AB, Box 191, SE-101 23 Stockholm, Sweden). The shares are registered on person. No share certificates have been issued for the shares or will be issued for the new shares. The ISIN code of the share in Cam-urus is SE0007692850.

leI codeCamurus’ LEI code is 5493003S6Z6VI7WYFQ06.

dividend policyIn accordance with the dividend policy adopted by the Board of Directors, Camurus will continue to focus on its strategy of devel-oping and expanding the Company’s clinical project portfolio further and pursuing commercial operations, and the available financial resources will be utilized to finance this strategy. Consequently, the Board of Directors does not intend to propose any dividend to share-holders until Camurus generates sustainable profitability.

Dividend historySEK 2017 2016Dividend per share – –


Articles of association

Adopted by the Extraordinary General Meeting on 7 October 2015.

1. Company nameThe name of the company is Camurus AB. The company is a public company (publ).

2. object of businessThe objective of the company’s business is to conduct research and production primarly within the fields of chemistry and biotechnology, sales of know-how and products within these fields, and to acquire and manage securities and other personal property and to conduct business compatible therewith.

3. registered officeThe registered office of the company shall be in the municipality of Lund.

4. Share capitalThe company’s share capital shall amount to not less than SEK 500,000 and not more than SEK 2,000,000.

5. number of sharesThe number of shares shall be not less than 20,000,000 and not more than 80,000,000.

6. Board of directorsThe board of directors shall consist of no less than three (3) and no more than ten (10) members.

7. AuditorsThe company shall have one (1) or two (2) auditors with no more than two (2) deputy auditors. As auditor shall be elected an authorized public accountant or a registered public accounting firm.

8. Annual general meetingThe annual general meeting shall be held no later than six (6) months after the end of the financial year. At the annual general meeting the following matters shall be addressed: 1. Election of the chairman of the meeting.2. Preparation and approval of the voting list. 3. Election of one or two persons to approve the minutes. 4. Determination of whether the meeting has been duly convened. 5. Approval of the agenda. 6. Presentation of the annual report and the auditor’s report, and if

applicable, the consolidated financial statements and the group auditor’s report.

7. Resolutions regarding: a. adoption of the income statement and the balance sheet, and,

if applicable, the consolidated income statement and the consoli-dated balance sheet;

b. appropriation of the company’s profit or loss according to the adopted balance sheet;

c. discharge from liability for the members of the board of direc-tors and the managing director.

8. Resolution regarding fees for the members of the board of direc-tors and fees for the auditors.

9. Resolution regarding the number of members of the board of directors and auditors and deputy auditors.

10. Election of members of the board of directors, as well as election of auditors and deputy auditors.

11. Any other matter on which the annual general meeting is required to decide pursuant to the Swedish Companies Act or the articles of association.

9. noticeNotice convening a general meeting shall be published in the Swed-ish Official Gazette (Sw. Post- och Inrikes Tidningar) and on the company’s website. It shall be advertised in Svenska Dagbladet that notice convening a general meeting has been made.

Shareholders that wishes to participate in a general meeting shall be recorded in a printout or other representation of the entire share register as at the date falling five weekdays (Sw. vardagar) prior to the meeting and notify the company of their intention to participate by the date specified in the notice convening the meeting. The last mentioned day must not be a Sunday, other public holiday, Saturday, Midsummer’s Eve, Christmas Eve or New Year’s Eve and not fall earlier than the fifth weekday prior to the meeting.

At a general meeting, shareholders may be accompanied by one or two assistants, however only if the shareholder has notified the company of the number of assistants in the manner stated in the previous paragraph.

10. financial yearThe financial year of the company shall comprise the period 1 Janu-ary to 31 December.

11. CSd CompanyThe company’s shares shall be registered in a central securities depository register in accordance with the Swedish Financial Instru-ments Accounts Act (1998:1479).


legal considerations and supplementary information

general corporate and group informationThe legal name of the Company (and its commercial name) is Cam-urus AB. Camurus’ Swedish corporate ID No. is 556667-9105 and the registered office of the Board of Directors is situated in Lund, Sweden. The Company was incorporated in Sweden on 8 Septem-ber 2004 and registered with the Swedish Companies Registration Office on 8 October 2004. The operations was initiated in 1991 and was conducted up until 2005 in Camurus Development AB, which today is a wholly own subsidiary to the Company. The Company is a Swedish public limited liability company governed by the Swedish Companies Act (aktiebolagslagen (2005:551)).

Camurus is the ultimate parent company of the Group, which comprises nine legal entities in eight countries, see the table below. Currently, all the companies except for Camurus Development AB, Camurus Inc and Cubosome Inc are operating.

Subsidiary CountryShares and

voting rights, %Camurus Development AB Sweden 100.0Camurus Inc USA 100.0Cubosome Inc USA 100.0Camurus GmbH Germany 100.0Camurus Ltd UK 100.0Camurus Oy Finland 100.0Camurus AS Norway 100.0Camurus SAS France 100.0Camurus Pty Ltd Australia 100.0

material agreementsCamurus has not entered into any material agreements during the past two years and has neither entered into any agreements which contains any rights or obligations which are material to Camurus (in both cases excluding agreements entered into in the ordinary course of business).

Camurus’ license agreement with Braeburn, which has been entered into in the ordinary course of business, contains rights and obligations which are material to Camurus. For a more detailed description of this license agreement, reference is made to “Partnership with Braeburn” in the section “Business and market description”.

Subscription and underwriting commitmentsSubscription undertakingsSeven larger shareholders in Camurus, together holding shares representing 69 percent of the total number of shares and votes in the Company, have undertaken in whole or in part to exercise their preferential rights in the rights issue and thereby subscribe for new shares corresponding to in whole or in part their respective holdings in the Company. These subscription undertakings amounts to approximately SEK 129 million, equivalent to approximately 32 percent of the rights issue (see breakdown in the table below). No compensation is paid for these subscription undertakings.

The aforementioned shareholders have also undertaken not to reduce their respective holdings in the Company up to and including the day on which the rights issue is fully registered by the Swedish Companies Registration Office and to vote in favor of the rights issue at the extraordinary general meeting.

Underwriting commitmentsIn addition to the subscription undertakings, certain existing share-holders, including Gladiator, the Fourth Swedish National Pension Fund, Grenspecialisten Förvaltning and Maven Investment Partners and also certain other external investors, including LMK Venture Partners and CVI Investments Inc. (through Heights Capital Man-agement) have underwritten subscription for additional shares at an aggregate amount of approximately SEK 190 million, corresponding to approximately 47 percent of the rights issue (see breakdown in the table below). The remaining approximately SEK 83 million of the rights issue is underwritten, subject to customary terms and con-ditions, by Joint Global Coordinators. For these underwriting com-mitments, Camurus will pay a fee of four percent of the underwritten amount, in total approximately SEK 8.9 million and also compensate the Joint Global Coordinators for costs relating to legal advisors and other expenses incurred in connection with the rights issue.

The Company has provided customary warranties and indemni-ties for the Joint Global Coordinators’ underwriting commitments, which are also subject to customary terms and conditions – including that Joint Global Coordinators shall be provided with legal disclo-sures and disclosures from the Company’s auditors with respect to the rights issue. The Joint Global Coordinators’ commitments are subject to customary termination provisions whereby they are entitled to terminate the agreement for breach of the guarantees pro-vided by the Company and if the conditions set for the commitments are not met. As is customary, the Company has also undertaken, for a period of 120 calendar days from the date of the underwriting commitments, not to carry out a capital increase, issue or similar action, sell shares or certain equity-related instruments or other sim-ilar measures, which would result in the transfer of economic rights associated with the shares (with some exceptions), without the prior written consent of the Joint Global Coordinators.

The underwriting commitments are conditional upon that Camurus’ Board of Directors and general meeting adopting the resolutions that are necessary to carry out the rights issue. These conditions have been met through the Board of Director’s resolution on the rights issue on 6 February 2019 and the general meeting’s approval thereof on 5 March 2019.

Unsecured commitmentsThe above-mentioned subscription and underwriting commitments are not secured. Consequently there is a risk that one or more of the above-mentioned parties are not able to fulfill their undertakings in whole or in part. See “Unsecured subscription and underwriting commitments” in “Risk factors”.


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Total commitmentsAltogether, the subscription and underwriting commitments total 100 percent of the rights issue as detailed in the below table. All commit-ments were entered into before and in conjunction with the Board’s rights issue resolution on 6 February 2019.

Shareholder/investorCurrent holding

Subscription under-taking (preferential rights), share of the

rights issue, %

Underwriting commitment,

MSEK

Underwriting commitment, share

of the rights issue, %

Total commitment,

share of the rights issue, %

Sandberg Development 20,414,978 18.61 – – 18.61Gladiator1) 2,495,000 6.50 50 12.41 18.91Fredrik Tiberg 1,512,551 1.24 – – 1.24Fjärde AP-fonden2) 896,116 2.33 50 12.41 14.74Backahill Utveckling 877,193 2.29 – – 2.29Grenspecialisten Förvaltning3) 387,721 1.01 30 7.44 8.45Maven Investment Partners Ltd4) 84,219 0.22 23 5.71 5.93CVI Investments Inc.5) (through Heights Capital Management)

– – 27 6.70 6.70

LMK Venture Partners6) – – 10 2.48 2.48Jefferies International Limited7) – – 57.63 14.30 14.30Carnegie Investment Bank AB8) – – 25.60 6.35 6.35Total 26,667,778 32.2 273.23 67.80 100.001) PO Box 7472, SE 103 92 Stockholm, Sweden. C/o Max Mitteregger kapitalförvaltning AB.2) Östersjögatan 11-13, 00180 Helsingfors, Finland. C/o Handelsbanken HCXI-F.3) PO Box 4042, SE 203 11 Malmö, Sweden. C/o SEB.4) 6 Bevis Marks, London EC3A 7BA, United Kingdom.5) South Church Street Ugland House, Box 309GT George Town, KY1-1104 Cayman Islands.7) PO Box 2025, SE 220 02 Lund, Sweden.8) Vintners Place, 68 Upper Thames Street, London EC4V 3BJ, United Kingdom.9) Regeringsgatan 56, SE 103 38 Stockholm, Sweden.

Declarations of intentSwedbank Robur Fonder and Enter Fonder, together representing approximately 3 percent of the total number of shares and votes in the Company, have expressed their intention to subscribe for their pro rata shares in the rights issue.

legal and arbitration proceedingsThe Group is present in several countries and from time to time the Group is subject to disputes, claims and administrative proceedings in the ordinary course of business. However, during the past 12 months the Group has not been part to any governmental, legal or arbitration proceedings (including any such proceedings which are pending or threatened of which Camurus is aware) which may have, or have had in the recent past, significant effects on Camurus’ finan-cial position or profitability.

related-party transactions The table below sets forth transactions between Camurus AB and related parties, including subsidiaries, during the financial years 2016–2018. No related-party transactions which, as a single trans-action or in their entirety, are material to the Group have occurred after 31 December 2018.

Purchase of services (SEK thousand) 2018 2017 2016The parent company – – 132Piir & Partners AB – 359 1,136Subsidiaries 78,274 33,266 –Total 78,274 33,625 1,268

Sale of services (SEK thousand) 2018 2017 2016The parent company – – 40Subsidiaries 17,789 10,332 –Total 17,789 10,332 40

Please also refer to note 28 on p. 73 in the 2017 annual report. For information on remuneration to the members of the Board of Directors and Group Management, see “Board of Directors, Group Management and auditor”.

Advisors, etc.Carnegie and Jefferies provide financial advice to Camurus in con-junction with the rights issue. From time to time, these advisors (and their affiliates) have in the ordinary course of business provided, and may in the future provide, various banking, financial, investment, commercial and other services to Camurus for which they have received, and may receive, compensation.

Mannheimer Swartling Advokatbyrå is Camurus’ legal advisor in the rights issue.


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Incorporation by reference, etc.Certain parts of Camurus’ consolidated financial statements for the financial years 2016–2017 as well as for the period January–Decem-ber 2018 are incorporated into this prospectus by reference and consequently form part of this prospectus and are to be read as part hereof. The said financial statements are included in Camurus’ annual reports for the financial years 2016 and 2017 and Camurus’ interim report for the period January–December 2018, where refer-ence is made as follows:

• Annual report 2017:1) directors’ report (p. 40-44), consolidated statement of comprehensive income (p. 47), consolidated balance sheet (page 48), change in consolidated equity (p. 50), consol-idated cash flow statement (p. 51), notes (p. 52–75) and audit report (p. 77–79).

• Annual report 2016:2) directors’ report (p. 40–44), consolidated statement of comprehensive income (p. 47), consolidated balance sheet (page 48), change in consolidated equity (p. 50), consol-idated cash flow statement (p. 51), notes (p. 52–75) and audit report (p. 77–79).

• Interim report January–December 2018:3) consolidated state-ment of comprehensive income (p. 13–14), consolidated balance sheet (p. 15), consolidated statement of changes in equity (p. 16), consolidated cash flow statement (p. 17) and notes (p. 21– 26).

Non-incorporated parts of the above reports contain information presented elsewhere in this prospectus or which is deemed not relevant to investors. Camurus’ consolidated financial statements for the financial years 2016–2017 have been audited by the Company’s auditor. The consolidated financial statements for January–Decem-ber 2018 have, as regards the period January–September 2018, been reviewed by the auditor.

documents on displayThe following documents (with the exception of annual reports of subsidiaries) can be downloaded on Camurus’ website, www.|camurus.|com. Copies of the documents can also be obtained at the head office of Camurus (Sölvegatan 41 A in Lund, Sweden) during the validity of this prospectus (regular office hours on business days). • Camurus’ articles of association. • Camurus’ annual reports for the financial years 2016–2017

(including audit reports). • Camurus’ interim report for the period January–December 2018. • Camurus’ subsidiaries’ annual reports for the financial years

2016–2017.

1) https://www.camurus.com/wp-content/uploads/2018/03/Camurus_AnnualReport_2017.pdf.2) https://www.camurus.com/wp-content/uploads/2017/04/annual_report_2016.pdf.3) https://mb.cision.com/Main/13456/2733331/986370.pdf.


Certain tax issues in Sweden

The following summary outlines certain Swedish tax consequences relating to holding of shares in the Company and the offer to subscribe for new shares for shareholders and holders of subscription rights in the Company. The summary is only applicable to individuals and limited liability companies (Sw. aktiebolag) tax resident in Sweden, unless otherwise stated. The summary is based on the laws of Sweden as currently in effect and is intended to provide general information only. The summary does not cover securities held by partnerships or held as current assets in business operations. Furthermore, the summary does not cover the specific rules on tax-exempt dividends and capital gains (including non-deductibility for capital losses) in the corporate sector, which may become applicable when shareholders hold securities that are considered to be held for business purposes (Sw. näringsbetingade andelar). Nor does the summary cover the special rules which may be applicable to holdings in companies which are, or previously were, closely-held companies, or to shares acquired pursuant to so-called qualified shares in closely-held companies. Moreover, the summary does not cover shares or other securities that are held in a so-called investment savings account (Sw. investeringssparkonto) and that are subject to special rules on standardised taxation. Special rules apply to certain categories of taxpayers, for example, investment companies and insurance companies. The tax treatment of each individual shareholder depends on such investor’s particular circumstances. Each holder of shares and subscription rights should, therefore, consult a tax advisor for information on the specific implications that may arise in an individual case, including the applicability and effect of foreign rules and tax treaties.

IndividualsCapital gains taxationUpon the sale or other disposition of listed shares or other equi-ty-related securities, such as subscription rights, a taxable capital gain or deductible capital loss may arise. Capital gains are taxed as capital income at a rate of 30 percent. The capital gain or loss is normally calculated as the difference between the sales proceeds, after deducting sales costs, and the tax basis (for specific informa-tion about the tax basis for subscription rights, see “Exercise and disposal of subscription rights” below). The tax basis for all equity-re-lated securities of the same class and type is calculated together in accordance with the “average cost method”. It should be noted that BTAs (paid subscribed shares) in this context are not considered to be of the same class and type as the existing shares that entitled the shareholder to the preferential right in the rights issue until the resolution of the rights issue has been registered with the Swedish Companies Registration Office.

Alternatively, upon the sale of listed shares, such as the shares in the Company, the tax basis may alternatively be determined as 20 percent of the sales proceeds, after deducting sales costs, under the “notional rule”.

Capital losses on listed shares and other listed equity-related securities are fully deductible against taxable capital gains on shares and on other listed equity-related securities, with the exception of units in securities funds or special funds that consist solely of Swedish receivables (Sw. räntefonder). Capital losses on shares and other equity-related securities which cannot be set off in this way can be deducted with up to 70 percent against other capital income. If there is a net loss in the capital income category, a tax reduction is allowed against municipal and national income tax, as well as against real estate tax and municipal real estate charges. A tax reduction is allowed with 30 percent on the portion of such net loss that does not

exceed SEK 100,000 and with 21 percent on any remaining loss. Such net loss cannot be carried forward to future income years.

Dividend taxationFor individuals, dividends on listed shares are taxed as income from capital at a rate of 30 percent. For individuals resident in Sweden, a preliminary tax of 30 percent is generally withheld by Euroclear or, in respect of nominee-registered shares, by the Swedish nominee.

Exercise and disposal of subscription rightsThe exercise of subscription rights does not give rise to any taxation. The acquisition cost for shares received is the issue price. If sub-scription rights used for subscribing for shares have been purchased or otherwise acquired (i.e. that have not been received based on a holding of existing shares) the tax basis for the subscription rights should be included when calculating the tax basis for the subscribed shares.

For shareholders that do not wish to utilise their preferential right to participate in the rights issue and therefore dispose of their subscription rights, a capital gain or loss is calculated. Subscription rights based on a holding of existing shares are considered to have been acquired at SEK 0. The total sales proceeds, after deduction of sales costs, are thus taxable. The “notional rule” is not applicable in this case. The tax basis for the original shares is not affected.For subscription rights purchased or otherwise acquired, the price paid for the rights constitutes the tax basis. The “notional rule” may be applied on disposal of listed subscription rights in this case. A subscription right that is not exercised or sold, and thus expires, is considered to have been disposed of at SEK 0.


C e r T A I n T A x I S S u e S I n S w e d e n

Limited liability companiesCapital gains and dividends taxationFor Swedish limited liability companies (Sw. aktiebolag) all income, including taxable capital gains and dividends, is taxed as business income. For a financial year commencing before 1 January 2019 the rate is 22 percent and for a financial year commencing from and including 1 January 2019 the rate is 21.4 percent.1) Capital gains and capital losses are calculated in the same manner as described above for individuals. Deductible capital losses on shares and other equity-related securities may only be deducted against taxable capital gains on such securities. Under certain circumstances, such capital losses may also be deducted against capital gains in another company in the same group, provided that the requirements for exchanging group contributions (Sw. koncernbidragsrätt) between the companies are met. A capital loss that cannot be utilised during a given income year may be carried forward and be offset against taxable capital gains on shares and other equity-related securities during subsequent income years, without limitation in time.

Exercise and disposal of subscription rightsThe exercise of subscription rights does not give rise to any taxation. The acquisition cost for shares received is the issue price. If sub-scription rights used for subscribing for shares have been purchased or otherwise acquired (i.e. that have not been received based on a holding of existing shares) the tax basis for the subscription rights should be included when calculating the tax basis for the subscribed shares.

For shareholders that do not wish to utilise their preferential right to participate in the rights issue, and therefore dispose of their subscription rights, a capital gain or loss is calculated. Subscription rights based on a holding of existing shares are considered to have been acquired at SEK 0. The total sales proceeds, after deduction of sales costs, are thus taxable. The “notional rule” is not applicable in this case. The tax basis for the original shares is not affected.

For subscription rights purchased or otherwise acquired, the price paid for the rights constitutes the tax basis. The “notional rule” may be applied on disposal of listed subscription rights in this case. A subscription right that is not exercised or sold, and thus expires, is considered to have been disposed of at SEK 0.

Specific tax considerations for shareholders or holders of subscription rights who are not tax residents in SwedenWithholding tax on dividendsFor shareholders not tax resident in Sweden who receive dividends from a Swedish limited liability company, Swedish withholding tax is normally payable. The tax rate is 30 percent. However, the tax rate is often reduced by tax treaties between Sweden and other countries for the avoidance of double taxation. The majority of Sweden’s tax treaties allow for a reduction of the Swedish tax to the tax rate stipu-lated in the treaty directly at the payment of dividends, provided that necessary information is available in relation to the person entitled to such dividends. In Sweden, Euroclear or, for nominee-registered shares, the nominee normally carries out the withholding. The receipt of subscription rights does not give rise to any obligation to pay withholding tax.

1) The rate of 21.4 per cent is applicable for a financial year that commences after 31 December 2018 but before 1 January 2021. For a financial year that commences from and including 1 January 2021 the rate is 20.6 per cent.

If a 30 percent withholding tax is deducted from a payment to a person entitled to be taxed at a lower rate, or if excessive withholding tax has otherwise been withheld, a refund can be claimed from the Swedish Tax Agency prior to the expiry of the fifth calendar year following the dividend distribution.

Capital gains taxationHolders of shares and subscription rights not tax resident in Sweden and whose holding is not attributable to a permanent establishment in Sweden are generally not liable for Swedish capital gains taxation on the disposal of shares or subscription rights. The holders may, however, be subject to tax in their country of residence. Under a specific tax rule, individuals that are not tax resident in Sweden may, however, be subject to tax in Sweden on the sale of certain securities (such as shares, BTAs and subscription rights) if they have been resident or lived permanently in Sweden at any time during the calendar year of such disposal or during any of the previous ten cal-endar years. The application of this rule may be limited by tax treaties between Sweden and other countries.


Selling and transfer restrictions

The distribution of subscription rights and the offer to subscribe for new shares in the Company by exercise of subscription rights as well as without subscription rights (the “Rights Issue”) to persons resident in, or who are citizens of, countries other than Sweden may be affected by the laws of the relevant jurisdiction. Investors should consult their professional advisers as to whether they require any governmental or other consent or need to observe any other formalities to enable them to exercise subscription rights or to subscribe for new shares without subscription rights.

generalCamurus has not taken and will not take any action to permit a public offering of the new shares being issued in the Rights Issue (through the exercise of the subscription rights or otherwise) in any jurisdiction other than Sweden. Receipt of this prospectus will not constitute an offer in those jurisdictions in which it would be illegal to make an offer and, in those circumstances, this prospectus is for information only and must not be copied or redistributed.

Except as otherwise disclosed in this prospectus, if an investor receives a copy of this prospectus in any jurisdiction other than Sweden, the investor may not treat the prospectus as constituting an invitation or offer to it, nor should the investor in any event deal in the subscription rights, paid subscribed shares/interim shares (betalda tecknade aktier (BTA)/interimsaktier) or new shares being granted or offered, respectively, in the Rights Issue (the “Securities”), unless, in the relevant jurisdiction, such an invitation or offer could lawfully be made to that investor, or the Securities could lawfully be dealt in without contravention of any unfulfilled registration or other legal requirements.

Accordingly, if an investor receives a copy of this prospectus, the investor should not distribute or send the same, or transfer the Securities to any person, in or into any jurisdiction where to do so would or might contravene local securities laws or regulations. If any investor forwards this prospectus into any such jurisdictions (whether under a contractual or legal obligation or otherwise), such investor should draw the recipient’s attention to the contents of this section. Except as otherwise expressly noted in this prospectus, the following applies: • the Securities may not be offered, subscribed for, sold or trans-

ferred, directly or indirectly, to or in the United States, Canada, Japan, Australia, New Zealand, South Africa, Hong Kong, Singa-pore or any other jurisdiction in which it would not be permissible to offer the Securities or where such action would require addi-tional prospectuses, registration or measures other than those pursuant to Swedish law (an “Ineligible Jurisdiction”, together the “Ineligible Jurisdictions”);

• the prospectus may not be sent to any person in any Ineligible Jurisdiction; and

• the transfer of subscription rights to an account of a shareholder or other person in an Ineligible Jurisdiction or of a citizen of an Inel-igible Jurisdiction (referred to as “Ineligible Persons”) does not constitute an offer to such persons of new shares and Ineligible Persons may not exercise subscription rights.

If an investor subscribes for, receives, transfers, trades or otherwise deals in the Securities, that investor will be deemed to have made, or, in some cases, be required to make, among other things, the

following representations and warranties to Camurus and any person acting on its behalf (unless such requirement is waived by Camurus): • the investor is not located in an Ineligible Jurisdiction; • the investor is not an Ineligible Person; • the investor is not acting, and has not acted, for the account or

benefit of an Ineligible Person; • the investor understands that the Securities have not been or will

not be registered under the United States Securities Act of 1933, as amended (the “Securities Act”) and may not be offered, sub-scribed for, exercised, pledged, sold, resold, allotted, delivered or otherwise transferred within the United States, or for the account or benefit of persons in the United States, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements under the Securities Act; and

• the investor may lawfully be offered, exercise, subscribe for and receive Securities in the jurisdiction in which it resides or is cur-rently located.

Camurus and any person acting on its behalf will rely upon the inves-tor’s representations and warranties. Any provision of false informa-tion or subsequent breach of these representations and warranties may subject the investor to liability.

If a person is acting on behalf of a holder of subscription rights (including, without limitation, as a nominee, custodian or trustee), that person will be required to provide the foregoing representa-tions and warranties to Camurus with respect to the exercise of subscription rights on behalf of the holder. If such person does not or is unable to provide the aforementioned representations and war-ranties, Camurus will not be bound to authorize the allocation of any Securities to that person or the person on whose behalf the other is acting.

Subject to the specific restrictions described below, if an investor (including, without limitation, its nominees, custodians and trust-ees) who is located outside of Sweden wishes to exercise, deal in or subscribe for Securities, the investor must satisfy itself as to full observance of the applicable laws of any relevant jurisdiction including obtaining any requisite governmental or other consents, observing any other requisite formalities and paying any taxes due in such territories.

The information set out in this section is intended as a gen-eral guide only. If the investor is in any doubt as to whether it is eligible to exercise subscription rights or otherwise subscribe for Securities, that investor should consult professional advis-ers without delay.

For shareholders who on the record date 7 March 2019 hold shares in Camurus through financial intermediaries, all subscription rights will initially be credited to such financial intermediaries for such shareholders’ accounts. A financial intermediary may not exercise


S e l l I n g A n d T r A n S f e r r e S T r I C T I o n S

any subscription rights on behalf of any person in the Ineligible Juris-dictions or any Ineligible Persons and may be required in connection with any exercise of subscription rights to certify the same.

Subject to certain exceptions, financial intermediaries are not permitted to send this prospectus or any other information about the Rights Issue into any Ineligible Jurisdiction or to any Ineligible Person. The crediting of subscription rights to the account of persons in Ineligible Jurisdictions or to Ineligible Persons does not constitute an offer of Securities to such persons. Nominees, which include banks, brokers, custodians and other financial intermediaries, holding for Ineligible Persons may consider selling any or all subscription rights held for the benefit of such persons to the extent permitted under their arrangements with such persons and applicable law and to remit the net proceeds to the accounts of such persons.

Subject to certain exceptions, exercise instructions or certifica-tions regarding subscription sent from or postmarked in any Ineligible Jurisdiction will be deemed to be invalid and the Securities will not be delivered to an addressee in any Ineligible Jurisdiction. Camurus reserves the right to reject any exercise or revoke any accepted exercise made in the name of any person who provides an address in an Ineligible Jurisdiction for exercise or delivery of Securities, who does not or is unable to represent or warrant that such person is not in an Ineligible Jurisdiction and is not an Ineligible Person, who is not acting on a discretionary basis for such persons, or who appears to Camurus or its agents to have executed its exercise instructions or certifications in, or dispatched them from, an Ineligible Jurisdiction. Furthermore, Camurus reserves the right, with sole and absolute dis-cretion, to treat as invalid any exercise or purported exercise of sub-scription rights which appears to it to have been executed, effected or dispatched in a manner that may involve a breach or violation of the laws or regulations of any jurisdiction.

Notwithstanding any other provision of this prospectus, Camurus reserves the right to permit a holder to exercise its subscription rights if Camurus in its absolute discretion is satisfied that the transaction in question is exempt from or not subject to the laws or regulations giving rise to the restrictions in question. Applicable exemptions in certain jurisdictions are described below. In any such case, Camurus does not accept any liability for any actions that a holder takes or for any consequences that such holder may suffer by Camurus’ accep-tance of the holder’s exercise of subscription rights.

None of Camurus, the Joint Global Coordinators, or any of their respective representatives is making any representation to any offeree, subscriber or purchaser of the Securities regarding the legal-ity of an investment in the Securities by such offeree, subscriber or purchaser under applicable laws. Each investor should consult with its own advisors and make its independent assessment of the legal, tax, business, financial and other consequences of a subscription or purchase of the Securities.

Investing in the Securities involves risks. See “Risk factors” for a discussion of risks that prospective investors should con-sider before investing in the Securities.

United StatesThe Securities have not been and will not be registered under the Securities Act or under the securities legislation of any state or other jurisdiction of the United States and may not be offered or sold, directly or indirectly, within the United States except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with any applicable securities legislation in any state or other juris-diction of the United States. The Securities are being offered and sold outside the United States in reliance on Regulation S under the Securities Act. Any offering of the Securities to be made in the United

States will be made by the issuer and only pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act, to a limited number of investors who (i) are both existing holders of shares in Camurus and qualified institutional buyers as defined in Rule 144A under the Securities Act (“QIB”) and (ii) have executed and delivered an investor letter, in form and sub-stance acceptable, to Camurus.

Accordingly, subject to certain limited exceptions, this document will not be sent to, and no subscription rights will be credited to, any shareholder with a registered address in the United States. In addition, Camurus and the Joint Global Coordinators reserve the right to reject any instruction in respect of the Securities sent by or on behalf of any securities account holder with a registered address in the United States.

Until 40 days after the commencement of the Rights Issue, an offer, sale or transfer of the Securities within the United States by a dealer (whether or not participating in the Rights Issue) may violate the registration requirements of the Securities Act. The Securities have not been approved or disapproved by the U.S. Securities and Exchange Commission (SEC), any state regulatory authority in the United States or any other U.S. regulatory authority nor have any of the foregoing authorities passed upon or endorsed the merits of the Rights Issue or the accuracy or adequacy of this document. Any rep-resentation to the contrary is a criminal offense in the United States.

Each person to which Securities are distributed, offered or sold within the United States will, by accepting delivery of this prospectus or by its subscription for Securities, be deemed to have represented, acknowledged and agreed, on its behalf and on behalf of any inves-tor accounts for which it is subscribing for Securities, as the case may be, that, among other things:

1. it is at the time of receipt of the prospectus, and at the time of any exercise by it of subscription rights, an existing shareholder of the Company and a QIB.

2. it understands and acknowledges that the Securities have not and will not be registered under the Securities Act, and that they may not be offered, sold or exercised, directly or indirectly, in the United States, other than in accordance with paragraph 4 below.

3. it understands that the subscription rights may only be trans-ferred, assigned or sold outside the United States in reliance on Regulation S under the Securities Act, and not in any case inside or into the United States.

4. as a purchaser in a private placement of securities that have not been registered under the Securities Act, it may only acquire sub-scription rights, paid subscribed shares/Interim shares and new shares upon the exercise of such subscription rights, for its own account, or for the account of one or more other QIBs for which it is acting as duly authorized fiduciary or agent with sole invest-ment discretion and with full authority to make the acknowledg-ments, representations and agreements herein, in each case for investment and not with a view to any resale or distribution of any such subscription rights or of any paid subscribed shares/Interim shares or new shares issuable upon exercise of the subscription rights.

5. it understands and agrees that, although offers and sales in the United States of the subscription rights are being made only to QIBs, and that the subscription rights may be exercised only by QIBs in the United States, neither such offers and sales nor such exercises are being made under Rule 144A, and that if in the future it or any such other QIB for which it is acting, as described in paragraph 4 above, or any other fiduciary or agent representing such investor decides to offer, sell, deliver, pledge or otherwise transfer any subscription rights, or any paid subscribed shares/Interim shares or new shares issued upon the exercise of sub-


scription rights, it and such other persons will do so only (i) pursu-ant to an effective registration statement under the Securities Act, (ii) with respect to paid subscribed shares/Interim shares or new shares, to a QIB in a transaction meeting the requirements of Rule 144A, (iii) outside the United States pursuant to Rule 904 under Regulation S under the Securities Act in an “offshore transaction” (and not in a pre-arranged transaction resulting in the resale of such subscription rights, paid subscribed shares/Interim shares or new shares into the United States), or (iv) in the case of new shares issued upon the exercise of subscription rights, in accor-dance with Rule 144 under the Securities Act and, in each case, in accordance with any applicable securities laws of any state or territory of the United States and any other jurisdictions. It under-stands that no representation can be made as to the availability of the exemption provided by Rule 144 under the Securities Act for the resale of new shares.

6. it understands that for so long as new shares issued upon the exercise of subscription rights are “restricted securities” within the meaning of U.S. federal securities laws, no such new shares may be deposited into any U.S. depositary receipt facility estab-lished or maintained by a depositary bank, other than a restricted depositary receipt facility, and that such new shares will not settle or trade through the facilities of the Depository Trust Company or any other U.S. exchange or clearing system.

7. it has received a copy of this prospectus and has had access to such financial and other information concerning Camurus as it has deemed necessary in connection with making its own invest-ment decision to exercise subscription rights and has consulted with its own independent advisers or otherwise satisfied itself concerning the legal, tax and other economic considerations related to exercising its subscription rights. It acknowledges and agrees that neither Camurus nor the Joint Global Coordinators nor any person representing Camurus or the Joint Global Coordi-nators has made any representation to it with respect to Camurus or the Offer other than as set forth in the prospectus. It will hold any offering materials, including the prospectus, it receives directly or indirectly from Camurus or the Joint Global Coordina-tors in confidence, and it understands that any such information received by it is solely for it and may not be redistributed or duplicated by it. It acknowledges and agrees that the Securities have not been offered to it by Camurus or the Joint Global Coor-dinators in any form of general solicitation or general advertising (in the meaning set forth in Regulation D under the Securities Act).

8. it, and each other QIB, if any, for whose account it may acquire subscription rights, paid subscribed shares/Interim shares or new shares, in the normal course of business, invests in or purchases securities similar to the Securities, has such knowledge and experience in financial and business matters that it is capable of evaluating the merits and risks of acquiring subscription rights and new shares and is aware that it must bear the financial risk of an investment in each subscription right and any paid subscrip-tion share and new share for an indefinite period of time and is able to bear such risk for an indefinite period. It confirms that it is acquiring subscription rights or new shares for itself and any other QIB, if any.

9. it understands that these representations and undertakings are required under United States securities laws and authorizes Camurus and the Joint Global Coordinators to produce these undertakings and the investor letter to any interested parties in any administrative or legal proceedings or official enquiry with respect to the matters covered herein.

10. it represents that if, in the future, it offers, resells, pledges or otherwise transfers the Securities, it shall notify such subsequent transferee of the transfer restrictions set out herein.

11. it is not an affiliate (as defined in Rule 501(b) under the Securities Act) of Camurus, and is not acting on behalf of an affiliate of Camurus.

12. it understands and acknowledges that Camurus, the Joint Global Coordinators and each of their respective affiliates and agents, and others, will rely upon the truth and accuracy of the foregoing representations, acknowledgements and agreements.

In addition, each person exercising subscription rights or otherwise subscribing for new shares will be deemed to have acknowledged and agreed that no person is authorized to give any information or make any representations other than those contained in the pro-spectus and, if given or made, such information or representations will not be relied upon as having been authorized by Camurus or the Joint Global Coordinators, nor will Camurus or the Joint Global Coor-dinators have any liability or responsibility therefore.

Each person to which Securities are distributed, offered or sold outside the United States will, by its subscription for, or purchase of, Securities, be deemed to have represented and agreed, on its behalf and on behalf of any investor accounts for which it is subscribing for Securities, as the case may be, that: • it is acquiring the Securities from Camurus in an “offshore transac-

tion” as defined in Regulation S under the Securities Act; and • the Securities have not been offered to it by Camurus by means of

any “directed selling efforts” as defined in Regulation S under the Securities Act.

Agreement of confidentialityAny recipient of this document in the United States is hereby notified that this document is being furnished to it on a confidential basis and must not be reproduced, resent or otherwise redistributed, in whole or in part, under any circumstances. Furthermore, recipients are authorized to use this document solely for the purpose of con-sidering a subscription for Securities and may not disclose any of the contents of this document or use any information herein for any other purpose. This document is personal to each recipient and does not constitute an offer to any other person or to the public generally to subscribe for or otherwise acquire Securities. Any recipient of this document agrees to the foregoing by accepting delivery of this document.

Enforcement of liabilities and service of processCamurus is a Swedish limited liability company. The majority mem-bers of the board of directors and the steering group are resident outside the United States. A substantial portion of the assets of Camurus and such persons are located outside the United States. As a result, it may not be possible for investors to serve writ of sum-mons upon Camurus or such persons or to enforce against them in U.S. courts judgments obtained in such courts. Original actions, or actions for the enforcement of judgments of a U.S. court, relating to the civil liability provisions of the federal or state securities laws of the United States are not directly enforceable in Sweden. The United States and Sweden do not have a treaty providing for reciprocal recognition and enforcement of judgments, other than arbitration awards, in civil and commercial matters. Accordingly, a final judg-ment for the payment of money rendered by a U.S. court based on civil liability will not be directly enforceable in Sweden. However, if the party in whose favor such final judgment is rendered brings a new lawsuit in a competent court in Sweden, that party may submit to the Swedish court the final judgment that has been rendered in the United States. Although a judgment by a federal or state court in the United States against the Company or the Group will neither be recognized nor enforced by a Swedish court, it may serve as evidence in a similar action in a Swedish court.


EEAWithin the European Economic Area (“EEA”), no public offering of Securities is made in other countries than Sweden. In other member states of the EEA which have implanted the Prospectus Directive, any offer of Securities may only be made to “qualified investors” as defined in Article 2.1 e) of the Prospectus Directive, or under other circumstances which do not require Camurus to publish any additio-nal prospectuses in the relevant member state under Article 3 of the Prospectus Directive. Each recipients of this prospectus will be con-sidered to have represented and guaranteed that they do not have or will not make any offer to the public in any member state of the EEA.

The term “public offering” refers to the definition under Article 2.1 d) of the Prospectus Directive. The term “Prospectus Directive” means European Parliament and Council Directive 2003/71/EC as well as any relevant implementing measures (including measures for the implementation of European Parliament and Council Directive 2010/73/EU amending the Prospectus Directive, etc.) in the relevant member state.

Other jurisdictionsThe Securities have not been and will not be registered in Canada, Japan, Australia, New Zealand, South Africa, Hong Kong, Singapore or any other jurisdiction outside Sweden and may not be offered, subscribed for, exercised, pledged, sold, resold, delivered or other-wise transferred, directly or indirectly, in or to any such jurisdiction other than in such exceptional cases when a prospectus would not be required under applicable laws and regulations of such jurisdiction.


glossary

505(b)(2) US submission which contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use

Acromegaly A disorder caused by overproduction of growth hormones resulting in abnormal body growthAgonist A drug or other substance that binds to and blocks a receptor and thereby stimulates the activity of the receptorAnalogue Similar molecular structureAntagonist A drug or other substance that binds to and blocks a receptor without stimulating the activity of the receptorBioadhesive A substance that is adhesive to biological surfaces Bioavailability The degree and rate at which a substance (as a drug) is absorbed by the body Buprenorphine Active ingredient that is strongly analgesic and that may be used for treatment of opioid dependence CAGR Compounded Annual Growth Rate, average annual growthCash pool Cash management technique employed by companiesCDF Cumulative distribution functionCE marking CE marking of a product is used within the EU/EEA to show that the manufacturer or importer has followed the

essential requirements regarding safety, health, performance etc. that are outlined in the applicable EU directivesCINV Chemotherapy-induced nausea and vomitingClinical trials Investigations performed in humans in order to study the properties of an investigational productCOWS Clinical Opiate Withdrawal Scale, a scale used for clinical evaluation of withdrawal symptoms caused by opiatesCSA US Controlled Substances Act of 1970DEA US Drug Enforcement Administration EEA European Economic AreaEMA European Medicines Agency, a decentralized agency of the EU, responsible for the scientific evaluation of medi-

cines developed by pharmaceutical companies for use in the EUEndocrine diseases Diseases affecting the endocrine system, i.e. the body’s production, secretion and response to hormonesEndometriosis A disease in which tissue that normally grows inside the uterus (endometrium) grows outside the uterus EU5 France, Germany, Italy, the United Kingdom and SpainEudraCT European Union Drug Regulating Authorities Clinical Trials, the EU database for clinical trials FDA Food and Drug Administration, the US food and drug authorityFDCA Federal Food, Drug and Cosmetic ActGauge The dimension of the outer diameter of an injection needle. The gauge value decreases when the outer diameter

increasesGCP Good Clinical PracticeGDO Glycerol dioleateGeneric drug A drug that has the same active ingredient as a brand name drug GMP Good Manufacturing PracticeGnRH Gonadotropin-Releasing HormoneHybrid application EU hybrid application depends partly on the results of tests on a reference medicine and partly on new data

from nonclinical and clinical trials, and other data to establish the properties of the productIFRS International Financial Reporting StandardsIGF-1 Insulin-like Growth Factor 1In vitro Biological process that takes place outside a living cell or organism In vivo Biological process that takes place in living cells and tissues in an organism Incidence Number of new cases per population at risk IND Investigational New Drug, classification that is required for development of a new drug in the US Intramuscular injection Injection of a drug in a muscle, e.g. the gluteal muscleIntravenous injection Injection of a drug into a veinLAIs Long-acting injectablesLeuprolide Active ingredient used for treatment of e.g. prostate cancer Lipids Group of compounds consisting of fat or fat-like substances Milestone payment Economic compensation obtained within a framework of a partner program when a specific goal has been

achieved Morbidity The incidence of a disease within a population Mortality The incidence of death or number of deaths within a populationNaloxone Active ingredient used as an antidote to reverse respiratory depression after opioid or opiate overdosesNanoparticle Microscopic particle that behaves as a whole unit


g l o S S A r y

NDA New Drug Application, application for approval from the FDA to commercialize a new drug in the USNET Neuroendocrine tumors, a group of different kinds of hormone producing tumorsOctreotide Active ingredient used for treatment of e.g. cancer Oral mucositis Inflammation of the oral mucosa that leads to ulcers and pain in the oral cavity Orphan drugs Drugs intended to treat serious or life-threatening diseases that are so rare that pharmaceutical companies are

reluctant to develop them for economic reasons PAH Pulmonary arterial hypertensionPeptide Molecule consisting of a chain of amino acidsPharmacodynamics The biochemical and physiological effects of a drug on the body Pharmacokinetics The fate of a drug within the body (i.e. the absorption, distribution, metabolism and excretion)Pharmacovigilance System for detection, assessment, understanding and prevention of adverse effects and other drug-related

problemsPre-clinical studies Studies performed in model systems, i.e. not in humansPrevalence The proportion of a population that is affected with a particular disease or conditionReconstitution Preparation of a drug before administration, often addition of a diluent to a powder RoW Rest of the WorldSetmelanotide An MC4 receptor agonist peptide for the treatment of rare genetic disorders of obesitySPC Soybean phosphatidylcholineSSA Somatostatin Anologues, the standard for safe and effective medical therapy for acromegaly and symptom

control in NETsSubcutaneous injection Injection of a drug under the skinSublingual Under the tonguethe Directive Directive 2001/83/EC of the European Parliament and of the Council of 06 November 2001 on the Community

code relating to medicinal products for human useTGA Therapeutic Goods Administration, the regulatory body for therapeutic goods (including medicines and medical

devices) in AustraliaToxicity The degree to which a substance is toxic Transdermal A route of administration wherein active ingredients are delivered across the skin for systemic distribution, e.g.

via patches or ointmentsViscosity A measure of how viscous or thick a fluid is WHO World Health Organization

8 3I N V I TAT I O N T O S U B S C R I B E F O R S H A R E S I N C A M U R U S A B

Addresses

Camurus ABHead officeVisiting addressSölvegatan 41 APostal addressIdeon Science Park223 70 LundSwedenTelephone: 046 286 57 30 www.|camurus.|com

financial advisorsCarnegie Investment Bank AB (publ)Regeringsgatan 56103 38 StockholmSwedenwww.|carnegie.|se

Jefferies International LimitedVintners Place68 Upper Thames StreetLondon EC4V 3BJUnited Kingdomwww.|jefferies.|com

legal advisorMannheimer Swartling AdvokatbyråBox 4291203 14 MalmöSwedenwww.|mannheimerswartling.|se

AuditorPricewaterhouseCoopers AB113 97 StockholmSwedenwww.|pwc.|se

Ideon Science Park, 223 70 Lund, Sweden www.|camurus.|com B

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invitation to subscribe for shares in camurus ab · 2019. 5. 24. · the rights issue in brief...

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